[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Astellas Pharma Global Development, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":628},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,63,95,119,150,176,204,228,255,281,308,344,374,394,417,439,467,494,521,551,573,606],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100636474","phase-3-enfortumab-vedotin-in-combination-with-pembrolizumab-vs-concurrent-chemoradiotherapy-ccrt-in-people-with-muscle-invasive-bladder-cancer-ev-309-100636474",false,"NCT07566156","Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)","A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE ENFORTUMAB VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB IN ADULT PARTICIPANTS WITH MUSCLE-INVASIVE BLADDER CANCER WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY","Inclusion Criteria:\n\n* Has histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology staged cT2-T4aN0M0\n* Tissue comprising muscle-invasive urothelial cancer must be submitted for clinical staging at baseline\n* Eligible for and agree to receive chemoradiotherapy and one of the protocol-specified radiosensitizing chemotherapy regimens\n* Fit for systemic therapy and elect bladder preservation, including participants who are ineligible for or have elected not to undergo cystectomy\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n\nExclusion Criteria:\n\n* Advanced or metastatic disease (N+, M1), non-urothelial carcinoma, diffuse or multifocal CIS, urothelial carcinoma or histological variant at any site outside the urinary bladder within previous 24 months prior to randomization except Ta\u002FT1\u002FCIS of the upper urinary tract including renal pelvis and ureter if the participant had undergone complete nephrectomy\n* Has received any prior systemic treatment, chemoradiation, and\u002For radiation for MIBC or NMIBC\n* Prior pelvic radiation for any reason\n* Inadequate bladder function\n* Other active malignancies within 3 years prior to randomization\n* Previously treated with enfortumab vedotin or other MMAE-based antibody-drug conjugates (ADCs)\n* Previously treated with a PD(L)-1 inhibitor, defined as a PD-1 inhibitor or PD-L1 inhibitor\n* Uncontrolled diabetes\n* Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted\n* Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection\n* Received major surgery (defined as requiring general anesthesia and \\>24 hour inpatient hospitalization) within 4 weeks prior to randomization\n* Known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin\n* Known genetic disorders associated with radiosensitivity (eg, ataxia telangiectasia, Nijmegen breakage syndrome, Fanconi syndrome)\n* Active keratitis or corneal ulcerations\n* History of autoimmune disease that has required systemic treatment in the past 2 years\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n* Prior allogeneic stem cell or solid organ transplant\n* Received a live attenuated vaccine within 30 days prior to randomization","ALL","18 Years",{"count":19,"type":20},390,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together as a bladder preservation approach to treat patients with muscle invasive bladder cancer. The study will compare these drugs to concurrent chemoradiotherapy that is usually used to treat this cancer (standard of care). The study will enroll patients with muscle-invasive bladder cancer (MIBC) who have cancer that has not spread outside the bladder.",[26,27],"Urothelial Cancer","Urinary Bladder Neoplasms",[29,30,31,32,33,34,35,36,37,38,39,27,40,41,42,43,44,45,46,26,47,48,49],"Urologic Neoplasms","Urogenital Neoplasms","Neoplasms by Site","Neoplasms","Female Urogenital Diseases","Female Urogenital Diseases and Pregnancy","Complications","Urogenital Diseases","Urinary Bladder Diseases","Urologic Diseases","Male Urogenital Diseases","Cisplatin","Fluorouracil","Mitomycin","Gemcitabine","Muscle Invasive Bladder Cancer","Enfortumab vedotin","Pembrolizumab","Urothelial Carcinoma","Bladder-sparing","Bladder Preservation","RECRUITING","2026-07-01",{"date":53,"type":54},"2026-07-02","ACTUAL",{"date":56,"type":54},"2026-05-11",{"date":58,"type":20},"2032-02-29",{"name":60,"class":61},"Astellas Pharma Global Development, Inc.","INDUSTRY",11,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100630515","phase-1-a-study-of-asp546c-in-adults-with-gastroesophageal-cancer-pancreatic-cancer-or-other-solid-tumors-100630515","NCT07488676","A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors","A Phase 1b\u002F2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants With CLDN18.2-expressing Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma, Pancreatic Adenocarcinoma or Other Solid Tumor Types","Inclusion Criteria:\n\n* Participant has a histologically confirmed diagnosis of gastroesophageal (gastric\u002FGEJ\u002Fesophageal) adenocarcinoma, pancreatic adenocarcinoma, or pan-tumor (cholangiocarcinoma, colorectal adenocarcinoma, NSCLC \\[adenocarcinoma\\], SCLC, ovarian mucinous carcinoma or invasive breast cancer \\[ER\u002FPR+HER2-; ER\u002FPR-HER2+; ER\u002FPR+HER2+ (triple positive); ER\u002FPR-HER2- (triple negative)\\].\n* Participant has radiologically confirmed uLA\u002Fm gastroesophageal (gastric\u002FGEJ\u002Fesophageal) adenocarcinoma, pancreatic adenocarcinoma or pan-tumor within 28 days prior to the first dose of study intervention.\n* Cohorts 1 to 3 only: Participant has measurable disease according to RECIST v1.1 within 28 days prior to the first dose of study intervention. For participants with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.\n* Cohort 4 only: Participant has radiologically evaluable disease (measurable and\u002For non-measurable) according to RECIST v1.1, within 28 days prior to the first dose of study intervention. For participants with only 1 evaluable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.\n* Participant's tumor expresses CLDN18.2.\n* Participant has received at least 1 line of therapy for uLA\u002Fm disease.\n* Participant has an ECOG performance status of 0 or 1.\n* Participant has a predicted life expectancy \\>= 12 weeks.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a women of childbearing potential (WOCBP)\n  * WOCBP who has a negative urine or serum pregnancy test at screening (Specific to Japan: with a medical interview), and agrees to follow the contraceptive guidance from the time of informed consent through at least 5 half-lives (45 days) plus 6 months after final investigational study intervention administration.\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (45 days) plus 6 months after final investigational study intervention administration.\n* Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 5 half-lives (45 days) plus 6 months after final investigational study intervention administration.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 5 half-lives (45 days) plus 3 months after final investigational study intervention administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 5 half-lives (45 days) plus 3 months after final investigational study intervention administration.\n* Male participant must not donate sperm during the treatment period and for 5 half-lives (45 days) plus 3 months after final investigational study intervention administration.\n* Participant must meet all of the criteria based on the locally analyzed laboratory tests collected within 14 days prior to the first dose of study intervention. In case of multiple local laboratory tests within this period, the most recent data should be used.\n* Participant is willing to provide or has sufficient tumor tissue for central biomarker assessment.\n* Participant agrees not to participate in another interventional study while receiving study intervention in the present study.\n\nExclusion Criteria:\n\n* Cohorts 1, 2 and 3 only: Participant's disease is of the non-adenocarcinoma histology or mixed histology containing adenocarcinoma.\n* Cohorts 1, 2 and 3 only: Participant has received \\> 2 prior lines of therapy for uLA\u002Fm disease.\n\n  * Participants in Cohort 4 (pan-tumor) may enroll regardless of the number of prior lines of therapy, if they are not eligible for, decline, or do not have any available standard of care treatment options.\n* Participant has complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting.\n* Participant has significant gastric bleeding or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to the first dose of study intervention and\u002For an untreated peptic ulcer disease that would preclude the participant from participation.\n* Participant has significant bleeding disorders or has had vasculitis within 3 months prior to the first dose of study intervention.\n* Participant has a history of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose of study intervention.\n* Participant has symptomatic, untreated brain metastases or meningeal carcinomatosis (carcinomatous meningitis) from the primary malignancy. A participant with stable central nervous system metastases for \\> 3 months without need of steroids for \\>= 2 weeks prior to the first dose of study intervention is eligible.\n* Participant has a past or current mental illness that is difficult to control.\n* Participant has unresolved pneumonitis or a history of non-infectious pneumonitis such as immune-related pneumonitis or radiation-induced pneumonitis for which the participant is taking glucocorticoids or needed glucocorticoids within 6 months prior to the first dose of study intervention.\n* Participant has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen \\[HBsAg\\]) or hepatitis C infection. Screening for these infections should be conducted if indicated per local requirements.\n\n  * If participant is negative for HBsAg, but hepatitis B core antibody (HBcAb) and\u002For hepatitis B surface antibody (HBsAb) positive, a hepatitis B DNA test will be performed; if the test is positive, the participant will be excluded.\n  * Participant with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results, is eligible.\n  * Participant treated for HCV with undetectable viral load results is eligible.\n* Participant has an active infection requiring systemic therapy that has not completely resolved within 7 days prior to the first dose of study intervention.\n* Participant has a malignancy for which treatment is required, has a history of another malignancy within the past 5 years, except malignancies for which participant received curative therapy without recurrence for the last 5 years (e.g., adequately resected non-melanoma skin cancer, localized prostate cancer), or had treatment for carcinoma in situ.\n* Participant has clinically significant third spacing (large amount of pleural fluid or ascites) that requires frequent percutaneous draining or requires placement of a drainage catheter for adequate control.\n* Participant has any AE from prior antitumor treatments that has not yet recovered to grade 0 or 1 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0 (except alopecia).\n* Participant has an active autoimmune disease or other medical condition that has required high dose systemic steroids at the time of screening.\n* Participant has known peripheral neuropathy \\> grade 1 (except when the sole neurological abnormality is absence of deep tendon reflexes).\n* Participant has sinusoidal obstruction syndrome, formerly known as veno-occlusive disease; if present, should be stable or improving.\n* Participant has significant cardiovascular disease, including any of the following:\n\n  * Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to the first dose of study intervention.\n  * History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes), cardiac arrhythmias requiring anti-arrhythmic medications (a participant with rate controlled atrial fibrillation for \\> 1 month prior to the first dose of study intervention is eligible) or obligate use of cardiac pacemaker.\n  * QTc interval \\> 470 msec\n  * Documented history or family history of congenital long QT syndrome.\n* Participant has ongoing or previous interstitial lung disease, active diverticulitis or solid organ or stem cell transplant.\n* Participant has a serious non-healing wound or bone fracture within 28 days prior to study intervention.\n* Participant has had a major surgical procedure within 28 days prior to the first dose of study intervention and has not completely recovered from the surgical procedure \\\u003C= 14 days prior to the first dose of study intervention.\n* Participant has received chemotherapy, immunotherapy or investigational therapy \\\u003C= 14 days prior to the first dose of study intervention and has not recovered from any related toxicity. Palliative radiotherapy is allowed and must be completed \\> 14 days prior to the first dose of study intervention.\n* Participant has received prior CLDN18.2 ADC. Prior treatment with CLDN18.2 monoclonal antibody or bi-specific T-cell engager is allowed.\n* Participant has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.\n* Participant has a known or suspected hypersensitivity to ASP546C or any components of the formulation used.\n* Participant has a clinically significant disease or comorbidity that in the opinion of the investigator may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.\n* Cohorts 1 and 2 (gastroesophageal adenocarcinoma) only: Participant has known HER2 positive status defined as immunohistochemistry (IHC) 3+ or IHC 2+\u002F in situ hybridization (ISH) +. ISH positive is defined as HER2\u002F chromosome enumeration probe 17 (CEP17) ratio ≥ 2.0 or an average HER2 copy number ≥ 6.0 signals\u002Fcell.",{"count":71,"type":20},150,[73,74],"PHASE1","PHASE2","This study will help find the most suitable dose of ASP546C in people with gastric cancer, gastroesophageal junction (GEJ) cancer, pancreatic cancer, and other specific solid tumors. GEJ is where the food pipe (esophagus) joins the stomach.\n\nThis study is in 2 parts. In both parts of the study, ASP546C will be given once in 3-week cycles. It will be given slowly through a tube into a vein. This is called an infusion.\n\nIn Part 1, people with gastric cancer or GEJ cancer can take part. They will receive an infusion of either a higher dose or a lower dose of ASP546C.\n\nIn Part 2, people with pancreatic cancer or who have one of the other solid tumors can take part. Part 2 doesn't include people with gastric cancer or GEJ cancer. All people in this part of the study will receive an infusion of the higher dose of ASP546C.\n\nPeople will visit the clinic on certain days to receive ASP546C and have health checks. The number of visits and checks done during the study will depend on the health of each person and whether they are still receiving infusions of ASP546C.",[77,78],"Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma","Pancreatic Adenocarcinoma",[77,78,80,81,82,83,84,85,86,87],"Cholangiocarcinoma","Colorectal adenocarcinoma","Non-small cell lung cancer (NSCLC) (adenocarcinoma)","Small cell lung cancer (SCLC)","Ovarian mucinous carcinoma","Invasive breast cancer","ASP546C","Claudin 18.2",{"date":53,"type":54},{"date":90,"type":54},"2026-05-04",{"date":92,"type":20},"2029-07-31",{"name":60,"class":61},14,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100629525","phase-2-a-study-to-find-out-if-enfortumab-vedotin-given-with-pembrolizumab-helps-people-with-muscle-invasive-bladder-cancer-keep-their-bladder-100629525","NCT07475806","A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder","An Open-label, Single-Arm, Phase 2 Study to Evaluate Enfortumab Vedotin Plus Pembrolizumab for Bladder Preservation in Participants With Muscle-invasive Bladder Cancer (EV-209)","Inclusion Criteria:\n\n* Participant has histologically-confirmed MIBC, stage cT2-T4aN0M0 or T1-T4aN1M0. NOTE: urothelial carcinomas (UCs) not originating from the bladder (e.g., upper tract \\[ureters, renal pelvis\\], urethra) are not eligible. UCs invading into the prostatic stroma with no histologic muscle invasion is allowed, provided that the extent of disease is confirmed via imaging.\n* Participant has predominant UC histology (≥ 50%). NOTE: Participants with mixed histology are eligible provided the urothelial component is ≥ 50% (participants whose tumors contain predominant \\[≥ 50%\\] plasmacytoid variant are not eligible). Participants whose tumors contain any neuroendocrine histology are not eligible.\n* Participant is deemed eligible for radical cystectomy and pelvic lymph node dissection.\n* Participant has accessible archival tumor tissue from the primary tumor, for which source and availability have been confirmed prior to study intervention. If no archival tumor tissue is available, the participant will have a biopsy to obtain tumor tissue prior to study intervention.\n* Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Have a transurethral resection of a bladder tumor within 60 days (+14 days) prior to screening (from the date of informed consent form signature).\n\nExclusion Criteria:\n\n* Participant has preexisting sensory or motor neuropathy Grade ≥ 2.\n* Participant has ≥ N2 disease or metastatic disease (M1) as identified by imaging\n* Participant has a history of uncontrolled diabetes mellitus within 3 months prior to screening. Uncontrolled diabetes (within 3 months before first dose) is defined as hemoglobin A1c (HbA1c) ≥ 8% or HbA1c between 7% and \\\u003C 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained. The lowest HbA1c during the screening period will be used to determine eligibility.\n* Participant has a second malignancy diagnosed within 3 years before first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Participant with non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance\u002Fwatchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed.\n* Participant has known active keratitis or corneal ulcerations. Participant with superficial punctate keratitis is allowed if the disorder is being adequately treated.\n* Participant has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids or has current pneumonitis\u002FILD.\n* Participant has a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n* Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.\n* Participant has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n\n  * Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n  * Brief (\\\u003C 7 days) use of systemic corticosteroids is allowed when use is considered standard of care.\n  * Participant with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma\u002Fatopy will not be excluded.\n  * Participant requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded.\n  * Participant with hypothyroidism that is stable with hormone replacement therapy or Sjögren's syndrome will not be excluded.\n* Participant has received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed death-ligand 2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).\n* Participant has received prior systemic anti-cancer therapy for MIBC\u002Fnon-muscle invasive bladder cancer (NMIBC), or received prior systemic anti-cancer therapy including investigational agents (including enfortumab vedotin or other monomethyl auristatin E-based antibody-drug conjugates) within 3 years prior to screening.\n\nNOTE: Prior treatment for NMIBC with intravesical instillation therapy such as Bacillus Calmette-Guérin or intravesical chemotherapy is permitted. Prior systemic treatment (including, but not limited to, anti-PD-1\u002FPD-L1 treatment with pembrolizumab, etc.) received for NMIBC is not permitted.\n\n* Participant has received a partial cystectomy of the bladder to remove any NMIBC or MIBC.\n* Participant has received any prior radiotherapy to the bladder.",{"count":103,"type":20},240,[74],"People with a type of bladder cancer called muscle-invasive bladder cancer have cancer that has spread into the muscle wall of the bladder. The standard treatment is to have chemotherapy, followed by surgery to completely remove the bladder. This has a significant impact on people with long-term life-altering changes. There are also limited options for people who cannot have chemotherapy or who do not want their bladder removed.\n\nStudies show that enfortumab vedotin, when given with pembrolizumab, can help people with advanced bladder cancer. This treatment has also worked well for people with muscle-invasive bladder cancer who can't receive chemotherapy when it was given before and after bladder-removal surgery. However, some people can't have or won't have this surgery. There is still a need for new treatments that let people keep their bladder. This is especially important for people who respond well to the enfortumab vedotin, when given with pembrolizumab, and may benefit from continuing this study treatment instead of having surgery.\n\nThe main aims of this study are to check how many people continue to respond well to enfortumab vedotin with pembrolizumab and how many people have their bladder intact after 2 years.\n\nPeople in this study will be adults who have muscle-invasive bladder cancer and are able to have surgery to remove the bladder.\n\nPeople cannot take part if they have nerve damage (sensory or motor neuropathy), have had certain other cancers, have diabetes that is not under control, or have had a transplant.\n\nPeople will receive infusions of enfortumab vedotin on the 1st and 8th day of 3-week (21-day) cycles. They will also receive pembrolizumab on the 1st day of every 3-week cycle. There will be safety checks at each visit with checks of the tumors at some visits. The doctors will continue to check for medical problems throughout the study.\n\nPeople will continue to receive study treatment unless their cancer doesn't improve after 9 cycles of study treatment, or until their cancer gets worse, they can't tolerate the study treatment, they start other cancer treatment, they or the doctor decides the person should stop receiving study treatment, or sadly they pass away.\n\nPeople's whose cancer gets worse or doesn't improve after 9 cycles may need bladder surgery, radiotherapy or chemotherapy. People will visit the clinic after they stop their study treatment, in which they will be asked about any medical problems and have a health check. After this, people will continue to have scans every 12 weeks (3 months) for the first 2 years until their cancer gets worse. After this, if their cancer doesn't get worse, they will continue to have scans every 24 weeks (6 months) for up to 5 years to check for any changes in their cancer. After people's cancer gets worse, they won't have any more scans but will have telephone health checks every 3 months.",[107],"Muscle-invasive Bladder Cancer",[109,110,49,46,111],"ASG-22CE","Enfortumab Vedotin","PADCEV",{"date":53,"type":54},{"date":114,"type":54},"2026-03-12",{"date":116,"type":20},"2031-04-30",{"name":60,"class":61},10,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":21,"phases":129,"briefSummary":130,"conditions":131,"keywords":136,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},"100585374","phase-3-a-study-of-zolbetuximab-together-with-pembrolizumab-and-chemotherapy-in-adults-with-gastric-cancer-100585374","NCT06901531","A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer","A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive","LUCERNA","Inclusion Criteria:\n\n* Participant has histologically confirmed gastric or Gastroesophageal Junction (GEJ) adenocarcinoma.\n* Participant has radiographically confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to randomization.\n* Participant has radiologically evaluable disease (measurable and\u002For nonmeasurable) according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1, ≤ 28 days prior to randomization. For participants with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.\n* Participant has Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0 to 1.\n* Participant has predicted life expectancy ≥ 12 weeks.\n* Participant must be a candidate to receive mFOLFOX6 or CAPOX and pembrolizumab.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of child bearing potential (WOCBP)\n  * WOCBP who has a negative urine or serum pregnancy test at screening (Specific to Japan: with a medical interview), and agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study interventions.\n  * Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study interventions).\n  * Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for 9 months after the final administration of oxaliplatin and for 6 months after final administration of all other study interventions.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period, and for 6 months after final investigational study intervention administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after the final investigational study intervention administration.\n* Male participant must not donate sperm during the treatment period and for 6 months after the final investigational study intervention administration\n* Participant has a Human Epidermal Growth Factor Receptor 2 (HER2) -negative tumor.\n* Participant's tumor expresses Claudin18.2 (CLDN18.2) in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.\n* Participant's tumor expresses Programmed death ligand (PD-L1) combined positive score (CPS) ≥ 1 as determined by central IHC testing.\n* Participants with known microsatellite instability-high or mismatch repair deficient status may enroll as long as they meet the PD-L1 positivity criteria.\n* Participant must meet all of the criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In case of multiple central laboratory data within this period, the most recent data should be used.\n* Participant agrees not to participate in another interventional study while receiving study intervention in the present study.\n\nExclusion Criteria:\n\n* Participant has prior severe allergic reaction or intolerance to zolbetuximab or other monoclonal antibodies, pembrolizumab, mFOLFOX6 or CAPOX.\n* Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting.\n* Participant has significant gastric bleeding and\u002For untreated gastric ulcers that would preclude the participant from participation.\n* Participant has unresolved pneumonitis or history of non-infectious pneumonitis such as immune-related pneumonitis, radiation induced pneumonitis.\n* Participant has history of central nervous system metastases and\u002For carcinomatous meningitis from gastric\u002FGEJ cancer.\n* Participant has a known history of a positive test for Human Immunodeficiency Virus (HIV) infection or known active Hepatitis B Surface Antigen (positive HBsAg) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements.\n\n  * For participants who are negative for HBsAg, but hepatitis B core antibody (HBcAb) positive, a hepatitis B DNA test will be performed and if positive the participant will be excluded.\n  * Participants with positive Hepatitis C virus (HCV) serology, but negative HCV RNA test results are eligible.\n  * Participants treated for HCV with undetectable viral load results are eligible.\n* Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.\n* Participant has active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization. Participants with stable autoimmune disease who are receiving physiologic replacement doses of hydrocortisone or its equivalent are allowed.\n* Participant has a clinically significant disease or comorbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.\n* Participant has another malignancy for which treatment is required.\n* Participant has known complete Dihydropyrimidine Dehydrogenase (DPD) deficiency (screening for DPD deficiency should be conducted per local requirements).\n* Participant has known peripheral neuropathy \\> grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the participant ineligible).\n* Participant has sinusoidal obstruction syndrome, formerly known as veno-occlusive disease, if present, should be stable or improving.\n* Participant has significant cardiovascular disease, including any of the following:\n\n  * Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization.\n  * History of clinically significant ventricular arrhythmias (i.e., sustained; ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes).\n  * QTc interval \\> 450 msec for male participants; QTc interval \\> 470 msec for female participants.\n  * History or family history of congenital long QT syndrome.\n  * Cardiac arrhythmias requiring anti-arrhythmic medications (participants with rate controlled atrial fibrillation for \\> 1 month prior to randomization are eligible).\n* Participant has ongoing or previous interstitial lung disease, active diverticulitis or peptic ulcerative disease, or solid organ or stem cell transplant or other uncontrolled or clinically significant medical disorders.\n* Participant has type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy or skin disorders (e.g., vitiligo, psoriasis or alopecia) not requiring systemic treatment are allowed.\n* Participant has received prior systemic chemotherapy and\u002For immunotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, except for a maximum of 1 treatment course of mFOLFOX6 (day 1 to 14) or CAPOX (day 1 to 21) with or without pembrolizumab. However, participants may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as their disease progression occurred at least 6 months after the last dose. Participant who has received treatment with herbal medications that have known antitumor activity \\> 28 days prior to randomization is allowed.\n* Participant has received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to randomization. Participant using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single-dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use is allowed.\n* Participant has had major surgical procedure ≤ 28 days before randomization and has not completely recovered from the surgical procedure ≤ 14 days before randomization.\n* Participant has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to randomization and has NOT recovered from any related toxicity. Palliative radiotherapy is allowed and must be completed \\> 14 days prior to randomization.\n* Participant has received prior CLDN18.2 agents.\n* Participant received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.\n* Participant has received other investigational agents or devices concurrently or within 28 days prior to randomization or within 5 half-lives of the drug, whichever is longer.\n* Participant has any condition which makes the participant unsuitable for study participation.\n* Participant has any concurrent disease, infection, or co-morbid condition that interferes with the ability of the participant to participate in the study, which places the participant at undue risk or complicates the interpretation of data.\n* Treatment with brivudine, sorivudine or their chemically related analogues within 28 days prior to randomization or within 5 half-lives of the drug, whichever is shorter, is strictly prohibited.\n* Pernicious anemia or other anemias due to vitamin B12 deficiency.\n* Participant has a known history of a positive test for tuberculosis or known active tuberculosis infection. NOTE: Screening for these infections should be conducted per local requirements.",{"count":128,"type":20},500,[23],"Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it.\n\nThe main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy.\n\nAdults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People can also take part if they need to take medicines like steroids to suppress their immune system. They cannot take part if they have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections.\n\nThe study treatments are either zolbetuximab with pembrolizumab and chemotherapy, or placebo with pembrolizumab and chemotherapy. People who take part will receive just 1 of the study treatments by chance. The people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in 6-week (42-day) cycles. The study treatment is mainly given to people slowly through a tube into a vein. This is called an infusion. People will receive study treatment as follows: Zolbetuximab or placebo: 1 infusion every 2 or 3 weeks (2 or 3 infusions in a cycle) together with: Chemotherapy (1 of the following types of chemotherapy): 1. CAPOX (capecitabine and oxaliplatin): 1 infusion of oxaliplatin every 3 weeks (2 infusions in a cycle). People will also take 1 tablet of capecitabine twice a day for 2 weeks (14 days) at the start of each cycle (Day 1) and again in the middle of each cycle (Day 22). After 8 study treatments people will receive capecitabine only. 2. Modified FOLFOX6 or mFOLFOX6 (5-fluorouracil, folinic acid and oxaliplatin): 1 infusion every 2 weeks (3 infusions in a cycle). After 12 study treatments people will receive folinic acid and fluorouracil only, instead of mFOLFOX6. Pembrolizumab: 1 infusion every 3 or 6 weeks (1 or 2 infusions in a cycle). People can be in the study and will receive study treatment until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People may receive pembrolizumab for up to 2 years. People will visit the clinic on certain days to receive their study treatment and have health checks. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample if they stop treatment because their cancer has worsened. People will visit the clinic after they stop their study treatment. People will be asked about any medical problems and will have a health check. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.",[132,133,134,135],"Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer","Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer","Metastatic Gastric Adenocarcinoma or Cancer","Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma",[137,138,139,135,87,140,141,142],"Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer","Locally Advanced Unresectable Gastric Adenocarcinoma Cancer","Metastatic Gastric Adenocarcinoma Cancer","PD-L1","Human epidermal growth factor receptor 2 (HER2) Negative","zolbetuximab",{"date":53,"type":54},{"date":145,"type":54},"2025-05-22",{"date":147,"type":20},"2028-09-30",{"name":60,"class":61},249,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":159,"conditions":160,"keywords":163,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},"100576014","a-study-to-learn-how-avacincaptad-pegol-izervay-is-used-in-clinical-practice-in-people-who-have-geographic-atrophy-100576014","NCT06779773","A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy","A Non-interventional, Observational Study to Evaluate Treatment Patterns and Safety of Avacincaptad Pegol (ACP\u002FIZERVAY™) in Routine Clinical Practice in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration","Inclusion Criteria:\n\n* Patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in 1 or both eyes\n* Patient with a decision to treat with intravitreal avacincaptad pegol (ACP) prior to enrollment\n* Patient willingness to complete the patient reported outcome (PRO).\n\nExclusion Criteria:\n\n* Patients who have any contraindication or are not eligible for treatment with ACP, including the following:\n\n  * Active ocular or peri-ocular infection in either eye\n  * Active, suspected intraocular inflammation in either eye\n  * Hypersensitive to ACP or to any ingredient in the formulation\n* Patients currently participating in an investigational program with interventions outside of routine clinical practice.\n* Patients who have received ACP in the eye being considered for enrollment. Note: Patients who have received or are receiving ACP in the fellow eye at baseline are eligible to be included in the study.\n* Patients who have received any intravitreal complement inhibitor other than ACP in either eye. Note: Patients who have received an intravitreal complement inhibitor other than ACP in either eye and have completed the 90-day washout period are eligible to be included in the study.",{"count":128,"type":20},"OBSERVATIONAL","This study is for people who have geographic atrophy due to age-related macular degeneration (AMD). AMD happens when the macula, the light-sensitive layer at the back of the eye called the retina, becomes damaged and causes a person's central vision to worsen. Geographic atrophy is an advanced form of AMD where cells in the retina waste away and die. Over time this can lead to permanent loss of vision.\n\nAvacincaptad pegol can help slow down the worsening or progression of geographic atrophy. Avacincaptad pegol is a treatment approved in the US to treat geographic atrophy.\n\nThis study is about collecting information on how people with geographic atrophy are treated in routine clinical practice. This includes recording any medical problems from avacincaptad pegol. This is known as an observational study. Information will be collected from the peoples' medical records during and after treatment. The people in this study will have geographic atrophy in 1 or both eyes and they and their doctor have decided they will be treated with avacincaptad pegol. The individual's doctor decides on treatment, not the study sponsor (Astellas).\n\nPeople that want to take part in the study will have eye examinations that they would usually have as part of their routine care. People will also be asked to complete surveys about their eye health. These surveys will occur when treatment starts and then every 6 months for the first 2 years. After 2 years the surveys will happen once a year. The people on the study can take part if their doctor provides treatment with avacincaptad pegol and they want to continue with the study. The people on the study can take part for around 5 years.",[161,162],"Geographic Atrophy","Macular Degeneration",[164,165,166,167,168],"Avacincaptad Pegol","IZERVAY™","Treatment patterns","Safety","Functional Outcomes",{"date":53,"type":54},{"date":171,"type":54},"2025-01-22",{"date":173,"type":20},"2030-10-31",{"name":60,"class":61},65,{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},"100636466","phase-3-a-study-to-compare-setidegrasib-asp3082-with-docetaxel-in-people-with-non-small-cell-lung-cancer-with-a-kras-g12d-mutation-100636466","NCT07566052","A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation","A Randomized, Open-label, Phase 3 Study of Setidegrasib (ASP3082) Versus Docetaxel in Participants With KRAS G12D-mutated Locally Advanced (Unresectable) or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on or After Platinum Based Chemotherapy and Checkpoint Inhibitor Therapy (CPI)","Inclusion Criteria:\n\n* Participant has histologically confirmed locally advanced (unresectable) or metastatic non-small cell lung cancer (NSCLC) with documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation result status, based on local or central testing.\n\n  * The participant's positive KRAS G12D mutation result (either in tumor tissue or plasma ctDNA) must be available prior to randomization.\n  * If the participant is enrolling based on a local testing result, the result may have been based on tissue or liquid (blood) testing. If the participant is enrolling via central testing, the eligibility sample must be from tissue.\n* Participant must have progressed or experienced disease recurrence on or after platinum based chemotherapy (which includes but is not limited to platinum combinations with pemetrexed, paclitaxel, etoposide or gemcitabine) in combination with anti-PD-1\u002FPD-L1 antibody OR platinum-based chemotherapy and anti-PD-1\u002FPD-L1 antibody (in either order) sequentially in the locally advanced (unresectable) or metastatic setting (participant who received anti PD-1\u002Fanti-PD-L1 antibody or platinum-based chemotherapy as first-line therapy in the locally advanced \\[unresectable\\] or metastatic setting may have received the combination of platinum-based chemotherapy and anti PD1\u002Fanti PD L1 antibody in the second line locally advanced \\[unresectable\\] or metastatic setting).\n\n  * No additional treatments are allowed in the locally advanced (unresectable) or metastatic setting, with the exception of: Anti-vascular endothelial growth factor (VEGF) therapy (e.g., bevacizumab), when administered in combination with platinum-based chemotherapy and\u002For anti-PD-1\u002FPD-L1 as part of a standard regimen in the locally advanced (unresectable) or metastatic setting and\n  * Anti-CTLA-4 antibodies (e.g., ipilimumab, tremelimumab), when administered in combination with anti-PD-1\u002FPD-L1 (with or without platinum-based chemotherapy) as part of a standard regimen in the locally advanced (unresectable) or metastatic setting.\n  * For the purposes of eligibility, for a participant who has received prior neoadjuvant or adjuvant therapy and has had recurrence during or within 6 months of completion of therapy, the neoadjuvant or adjuvant therapy will be counted as a line of systemic therapy in the locally advanced (unresectable) or metastatic setting (for those who received perioperative therapy, the entire course will be counted as a line of systemic therapy in the locally advanced (unresectable) or metastatic setting).\n  * For the purposes of eligibility, for a participant with a history of unresectable Stage III disease who has received prior multi-modal therapy and has had recurrence on or within 6 months of completion of therapy, the multi-modal therapy will be counted as a line of systemic therapy in the locally advanced (unresectable) or metastatic setting. If chemoradiation was followed by treatment with checkpoint inhibitor therapy (CPI) without documented progression between chemoradiation and CPI, the entire treatment course will be counted as a line of systemic therapy in the locally advanced (unresectable) or metastatic setting, for the purposes of eligibility.\n  * Maintenance therapy following platinum doublet-based chemotherapy is not considered a separate line of therapy.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP).\n  * WOCBP who has a negative urine or serum pregnancy test at screening (Specific to Japan: with a medical interview) and agrees to follow the contraceptive guidance from the time of informed consent through ≥ 6 months after the final setidegrasib administration or ≥ 2 months after the final docetaxel administration, as applicable.\n  * Must not be breastfeeding or lactating starting at screening and throughout the investigational period and for ≥ 6 months after the final setidegrasib administration or ≥ 2 months after the final docetaxel administration, as applicable. (Note that this is stricter than some docetaxel product information\u002Flabeling documents due to the uncertainty regarding excretion of docetaxel in human milk.)\n  * Must not donate ova starting at first administration of study intervention and throughout the investigational period and for ≥ 6 months after the final setidegrasib administration or ≥ 2 months after the final docetaxel administration, as applicable.\n* Participant consents to and provides a baseline tumor tissue and plasma specimen during prescreening and\u002For screening.\n* Participant has an ECOG performance status of 0 or 1 within 7 days prior to randomization.\n\nExclusion Criteria:\n\n* Participant has known untreated or symptomatic central nervous system (CNS) metastases. Participant with previously treated brain metastases may be eligible if they have stable CNS disease for ≥ 2 weeks prior to randomization, all neurologic symptoms have returned to baseline, there is no evidence of new or enlarging brain metastases on brain imaging performed within 28 days prior to randomization and they are receiving ≤ 10 mg\u002Fday of prednisone or equivalent. Participants with untreated CNS metastases, even if asymptomatic, are not eligible.\n* Participant has mixed small-cell lung cancer and NSCLC histology.\n* Participant has leptomeningeal disease as a manifestation of the current malignancy.\n* Participant has another prior malignancy active (i.e., requiring treatment, including hormonal therapies, or intervention) within the previous 2 years different from the primary malignancy for this study, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.\n* Participant has known hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen \\[HBsAg\\]-positive or anti HBV core antibody-positive) or known hepatitis C virus (HCV) (defined as HCV RNA \\[qualitative\\] detected) infection.\n* Participant with human immunodeficiency virus (HIV) infection may be eligible if the participant has not had an opportunistic infection within the past 12 months. Participant must be on established antiretroviral therapy for ≥ 4 weeks, have a CD4+ T cell ≥ 200 cells\u002FµL and must have an HIV viral load \\\u003C 400 copies\u002FmL prior to randomization (HIV testing is not required unless mandated by the local health authority).\n* Participant has current grade ≥ 2 peripheral neuropathy.\n* Participant has uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Participant with PleurX catheters in place may be considered for the study with medical monitor approval.\n* Participant has received therapeutic or palliative radiation therapy within 14 days prior to randomization (see first Exclusion Criteria for CNS metastases); participant must have recovered from all radiotherapy related toxicity to ≤ grade 1, with the exception of alopecia (any grade of alopecia allowed).\n* Participant has a known actionable mutation for which an approved targeted therapy is locally available, including, but not limited to, KRAS G12C mutation, EGFR mutation (exon 19 deletions, exon 21 L858R point mutation, T790M, exon 20 insertion), ALK or ROS1 rearrangement, NTRK fusion, NRG1 fusion, BRAF V600E mutation, MET exon 14 skipping mutation, RET rearrangement or HER2 activating mutation.\n* Participant has received prior treatment with either docetaxel or a KRAS-targeting agent (including KRAS directed inhibitors, degraders, siRNA, vaccines and cellular therapies).\n* Participant requires treatment with concomitant drugs that are strong inhibitors or inducers of cytochrome P450 (CYP)3A or CYP2D6 or strong inhibitors of organic anion transporting polypeptide 1B1 (OATP1B1) or organic anion transporting polypeptide 1B3 (OATP1B3).",{"count":184,"type":20},356,[23],"Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. The first treatment is usually chemotherapy, given with another treatment that targets specific proteins on cancer cells. If the cancer gets worse, the next main treatment is usually a medicine called docetaxel. This treatment doesn't stop most people's cancer from getting worse for very long. Other treatments are needed to improve outcomes in people with NSCLC.\n\nGenes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Many people with NSCLC have a faulty KRAS gene in their tumor. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation.\n\nSetidegrasib (ASP3082) is thought to remove some of the abnormal proteins made from the faulty KRAS gene. Before setidegrasib can become available as a treatment, studies need to be done.\n\nThis study is for people with NSCLC with a faulty KRAS gene in their tumor. In this study, some people will be given setidegrasib and some people will be given docetaxel. The main aims are to learn how long people who are given setidegrasib live with cancer without it getting worse, compared to people who are given docetaxel, and if they live for longer. Other aims are to check tumor response, symptoms, how the body processes setidegrasib, and its safety, compared with docetaxel.\n\nThe main aims of study are to learn how long people who are given setidegrasib live with cancer without it getting worse, compared to people who are given docetaxel and if people who are given setidegrasib live for longer compared to people who are given docetaxel.\n\nPeople in this study will be adults with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) with the G12D mutation in their KRAS gene. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They have had no more than 2 previous treatments for their cancer. The key reasons people cannot take part are if they have different faulty genes in their tumor which can be targeted with other treatments, have symptomatic or untreated cancers that have spread from the lung into the brain or nervous system, their cancer has spread to the thin tissue that covers the brain and spinal cord (leptomeningeal disease), or they have recently had other active cancers that required treatment.\n\nIn this study, people will either receive setidegrasib or docetaxel. Whether people receive setidegrasib or docetaxel is decided by chance, not by the study doctor. Both study treatments are given slowly through a tube into a vein (infusion). People will continue to receive study treatment until their cancer gets worse, they can't tolerate the study treatment, they start other cancer treatment, they or the doctor decides the person should stop receiving study treatment, or sadly, they pass away. Some people on docetaxel may be able to switch to setidegrasib during the study if their cancer becomes worse. There will be safety checks at each visit, and the doctors will continue to check for medical problems and people's wellbeing throughout the study. People will continue to have scans of their tumor every 6 weeks for the first year, then every 9 weeks until their cancer becomes worse. After people's cancer becomes worse, clinic staff will telephone people every 12 weeks to check on their cancer.",[188],"Non-small Cell Lung Cancer (NSCLC)",[190,191,192,193,194],"Non-small cell lung cancer (NSCLC)","ASP3082","setidegrasib","KRAS G12D","Docetaxel","2026-06-29",{"date":197,"type":54},"2026-06-30",{"date":199,"type":54},"2026-04-28",{"date":201,"type":20},"2030-06-30",{"name":60,"class":61},5,{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":21,"phases":213,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},"100603707","phase-1-a-study-of-gilteritinib-in-adults-with-advanced-alk-positive-non-small-cell-lung-cancer-nsclc-100603707","NCT07140016","A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)","A Phase 1b Study of Gilteritinib in Participants With Locally Advanced or Metastatic NSCLC With ALK Rearrangement After Prior Treatment With an ALK Inhibitor","Inclusion Criteria:\n\n* Participant has histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) with a documented anaplastic lymphoma kinase (ALK) rearrangement and is not amenable to curative intent treatment.\n* Participant is willing to submit, prior to enrollment, a fresh tumor tissue sample that was collected after completion of the most recent anti-cancer treatment and before the first dose of study intervention. If it is not medically feasible for a participant to provide a fresh tumor tissue sample, enrollment into the study should be confirmed with the Astellas medical monitor. In this case, an archival tumor tissue sample must be provided.\n* Participant must have at least one prior line of ALK inhibitor-based therapy and meet one of the following criteria:\n\n  * Participant received alectinib as the only prior ALK inhibitor regimen. Participant is ineligible or unable to tolerate approved and available second-line therapy or is determined to potentially benefit from gilteritinib in this setting. Participant is eligible if chemotherapy was received in the neoadjuvant or adjuvant setting, and relapse or disease progressed after 12 months from completion of the treatment.\n  * Participant received lorlatinib as one of the prior ALK inhibitor regimens.\n* Participant has measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n* Participant must have had progression or recurrence of NSCLC during or following receipt of the most recent therapy.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP).\n  * WOCBP who has a negative urine or serum pregnancy test within 7 days prior to the first dose of study intervention and agrees to follow the contraceptive guidance from the time of informed consent through at least 180 days after final study intervention administration.\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 60 days after final study intervention administration.\n* Female participant must not donate ova starting at the first administration of study intervention and throughout the investigational period and for 180 days after final study intervention administration.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 120 days after final study intervention administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 120 days after final study intervention administration.\n* Male participant must not donate sperm during the treatment period and for 120 days after final study intervention administration.\n* Participant must meet the criteria as indicated on the clinical laboratory tests.\n* Participant agrees not to participate in another interventional study while receiving study intervention in the present study\u002Fparticipating in the present study.\n\nExclusion Criteria:\n\n* Participant has known oncogenic driver alterations other than ALK rearrangement.\n* Participant has symptomatic central nervous system (CNS) metastases or leptomeningeal metastasis.\n* Participant has a history of malignancy other than NSCLC within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix or malignancy considered cured with minimal risk of recurrence).\n* Participant had major surgery (e.g., requiring general anesthesia) within 4 weeks prior to first dose of study intervention, or will not have fully recovered from surgery, or has surgery planned during the study treatment.\n* Participant has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior anti-cancer treatment.\n* Participant has\u002Fhad febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to first dose of study intervention.\n* Participant has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease or a family history of long QT syndrome.\n* Participant has a history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study intervention.\n* Participant has a history of interstitial pneumonia.\n* Participant had completed target therapy, radiotherapy, chemotherapy, biologics and\u002For immunotherapy within 14 days prior to first dose of study intervention.\n* Participant requires treatment with strong inducers of cytochrome P450 (CYP) 3A.\n* Participant requires treatment with concomitant drugs that target serotonin 5HT1 or 5HT2B receptors or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the participant.\n* Participant has received any investigational therapy within 14 days or 5 half-lives, whichever is longer, prior to screening.\n* Participant has a mean Fridericia-corrected QT interval (QTcF) of \\> 450 msec at screening.\n* Participant has known active hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen (HBsAg)-positive and\u002For anti-HBV core antibody-positive) or known active hepatitis C virus (HCV) infection (defined as HCV RNA \\[qualitative\\] detected).\n\n  * Participant with HBsAg-positivity and\u002For anti-HBV core antibody-positivity but with a negative HBV DNA PCR assay is permitted with appropriate antiviral prophylaxis or routine monitoring according to local practice.\n  * Participant who has been curatively treated for HCV infection is permitted if he\u002Fshe has documented sustained virologic response of 12 weeks.\n* Participant has a known history of human immunodeficiency virus (HIV) infection with acquired immunodeficiency syndrome (AIDS)-related complications.\n* Participant has echocardiogram (ECHO) or multigated acquisition scan (MUGA) at screening revealing left ventricular ejection fraction \\\u003C 45%.\n* Participant has any condition that makes the participant unsuitable for study participation.\n* Participant has a known or suspected hypersensitivity to gilteritinib or any components of the formulation used.",{"count":212,"type":20},40,[73],"Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Some people with non small cell lung cancer (NSCLC) have a faulty ALK gene. ALK stands for anaplastic lymphoma kinase. People with NSCLC who have the faulty ALK gene are called ALK-positive. ALK inhibitors are an approved treatment for people with ALK positive NSCLC. Some people stop responding to treatment with ALK inhibitors over time due to more changes happening in their faulty ALK gene, so there is an unmet medical need. Gilteritinib is an approved treatment for people with acute myeloid leukemia (AML) with the faulty FLT3 gene who haven't responded to previous treatment, or their cancer came back after previous treatment. Gilteritinib also blocks changes in the ALK gene which could help people with ALK-positive NSCLC. A study needs to be done with gilteritinib in people with ALK-positive NSCLC.\n\nThe main aim of the study is to check the safety of gilteritinib in people with ALK-positive NSCLC and if they tolerate gilteritinib.\n\nPeople in this study will be adults with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC). Locally advanced means the cancer has spread to nearby tissue. Metastatic means the cancer has spread to other parts of the body. They have stopped responding to treatment with ALK inhibitors, including alectinib or lorlatinib, over time. The key reasons people cannot take part are if they have symptomatic cancers in the brain or nervous system, their cancer has spread to the thin tissue that covers the brain and spinal cord (leptomengingeal metastasis), have recently had or planning to have major surgery, have certain heart conditions, or have recently had an infection, a stroke or mini-stroke.\n\nPeople in the study will take tablets of gilteritinib once a day in a 28-day cycle. They may be given up to 2 different doses of gilteritinib. People in the study will start on the lower dose but can eventually switch to the higher dose if they tolerate the lower dose and meet the safety checks.\n\nWhilst taking gilteritinib, people will have regular scans of their tumors. People will continue taking gilteritinib until their cancer gets worse, they have medical problems from gilteritinib that they can't tolerate, they ask to stop taking gilteritinib, they start other cancer treatment or, sadly pass away. People will visit the clinic about 7 days and then 30 days after they stop taking gilteritinib. They will be asked about any medical problems and will have a safety check. After this, people who stopped taking gilteritinib, but their cancer hadn't become worse, will continue to have regular scans of their tumors. If their cancer does get worse, they will no longer have scans of their tumors. After finishing gilteritinib, people will be phoned every 12 weeks to check on their health. People will be in the study for up to 4 years, depending on how they respond to gilteritinib.",[188,216],"Anaplastic Lymphoma Kinase (ALK) Positive",[190,216,218],"gilteritinib","2026-06-25",{"date":221,"type":54},"2026-06-26",{"date":223,"type":54},"2025-09-22",{"date":225,"type":20},"2029-12-31",{"name":60,"class":61},16,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":21,"phases":237,"briefSummary":238,"conditions":239,"keywords":243,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},"100624410","phase-3-a-study-to-evaluate-the-effectiveness-and-safety-of-setidegrasib-given-with-either-mfolfirinox-or-nalirifox-chemotherapies-in-people-with-pancreatic-cancer-100624410","NCT07409272","A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer","A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination With mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants With KRAS G12D Mutated Metastatic Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n* Participant has histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) with documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation based on local or central testing (confirmation of a participant's positive KRAS G12D mutation result must be available prior to randomization).\n* Participant has no option for surgical resection or radiotherapy with curative intent.\n* Participant consents to and provides a baseline tumor tissue specimen for the study during screening. The sample must meet the requirements described in the laboratory manual and the tumor sample guidance.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 within 7 days prior to randomization.\n* Participant has adequate organ function as indicated by the following laboratory values within 7 days prior to randomization (if a participant has received a recent blood transfusion, the latest laboratory tests must be obtained ≥ 14 days after any blood transfusion). The laboratory values prior to the initiation of the first dose of setidegrasib\u002Fplacebo (or mFOLFIRINOX\u002FNALIRIFOX, if chemotherapy is administered during the screening period) should be used to determine eligibility. Participants who receive mFOLFIRINOX\u002FNALIRIFOX during the screening period must meet these criteria within 7 days prior to the start of on-treatment chemotherapy (i.e., C1D1).\n* Participant agrees not to participate in another interventional study while receiving study intervention in the present study (participant who is currently in the follow-up period of an interventional clinical trial is allowed).\n\nExclusion Criteria:\n\n* Participant has neuroendocrine, acinar pancreatic carcinoma or pancreatic cancer with squamous\u002Fadenosquamous features.\n* Participant has another prior malignancy active (i.e., requiring treatment, including hormonal therapies, or intervention) within the previous 2 years different from the primary malignancy for this study, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.\n* Participant has chronic inflammatory bowel disease, bowel obstruction and\u002For severe uncontrolled diarrhea.\n* Participant has peripheral sensory neuropathy with functional impairment.\n* Participant has ascites and\u002For pleural effusion that require invasive interventions within 30 days prior to randomization or have an indwelling drainage catheter.\n* Participant has symptomatic pulmonary embolism or pulmonary embolism not being treated with anticoagulation.\n* Participant has a history of interstitial lung disease or pulmonary fibrosis.\n* Participant has uncontrolled seizure disorder or refractory to antiepileptics.\n* Participant has known homozygous uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphism.\n* Participant has had a myocardial infarction, unstable angina or coronary artery bypass surgery within 6 months prior to randomization or currently has an uncontrolled illness including but not limited to symptomatic congestive heart failure, clinically significant cardiac disease (e.g., cardiomyopathy, infiltrative cardiac disease, etc.), unstable angina pectoris, cardiac arrhythmia, obligate use of a cardiac pacemaker or long QT interval (QT) syndrome.\n* Participant has received any prior systemic therapy for their metastatic PDAC (except with up to 2 doses \\[i.e., 28 days; 1 cycle\\] of mFOLFIRINOX or NALIRIFOX during the screening period. If a participant received \\[neo\\]adjuvant chemotherapy, tumor recurrence or disease progression must have occurred ≥ 6 months after completing the last dose of the \\[neo\\]adjuvant therapy).\n* Participant has had prior treatment with a KRAS G12D-targeted agent.\n* Participant has a corrected QT interval by Fridericia (QTcF) (single electrocardiogram \\[ECG\\]) \\> 470 msec during the screening period.",{"count":236,"type":20},614,[23],"Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer. The first treatment that people usually receive is chemotherapy. At the time this study started, some of the main standard chemotherapies for pancreatic cancer were mFOLFIRINOX or NALIRIFOX.\n\nGenes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Many people with pancreatic cancer have a faulty KRAS gene. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation.\n\nThis study is about setidegrasib given with chemotherapy in people with pancreatic cancer who have the KRAS G12D mutation. Before setidegrasib can become an approved treatment, clinical studies need to be completed to understand how it works and how safe it is.\n\nThe main aim is to learn if people who are given setidegrasib with chemotherapy live for longer than people who are given placebo with chemotherapy. Other aims are to learn if setidegrasib delays the cancer and symptoms returning, how the body processes setidegrasib, and its safety, when given with chemotherapy.\n\nPeople in this study will be adults with metastatic pancreatic cancer with the G12D mutation in their KRAS gene. Surgery or radiotherapy will not be an option to cure their cancer.\n\nPeople cannot take part if the cancer cells have spread to the thin tissue covering the brain and spinal cord (leptomeningeal disease), have symptoms of cancer in the brain or nervous system, or have recently had some other cancers that required treatment.\n\nIn this study, people are given either setidegrasib with mFOLFIRINOX or NALIRIFOX chemotherapy, or a placebo with mFOLFIRINOX or NALIRIFOX chemotherapy. Whether people receive setidegrasib or placebo is decided by chance. The study doctor decides which chemotherapy (mFOLFIRINOX or NALIRIFOX) people receive. People will only receive NALIRIFOX chemotherapy (with setidegrasib or placebo) after the safety of setidegrasib with NALIRIFOX chemotherapy has been confirmed in another ongoing setidegrasib study. All of the study treatments are given slowly through a tube into a vein (infusion). People will continue to receive study treatment until their cancer gets worse, they can't tolerate the study treatment, they start other cancer treatment, they or the doctor decides the person should stop receiving study treatment, or sadly they pass away. There will be safety checks at each visit, and the doctors will continue to check for medical problems and people's wellbeing throughout the study.",[240,241,242],"Pancreatic Cancer","Metastatic Pancreatic Cancer","Metastatic Pancreatic Adenocarcinoma",[240,241,242,191,192,193,244,245,246],"PDAC","mFOLFIRINOX","NALIRIFOX","2026-06-24",{"date":219,"type":54},{"date":250,"type":54},"2026-02-17",{"date":252,"type":20},"2029-08-31",{"name":60,"class":61},34,{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":265,"conditions":266,"keywords":269,"overallStatus":274,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":278,"leadSponsor":280,"locationsCount":4},"100644673","phase-3-a-study-of-asp2138-together-with-chemotherapy-and-pembrolizumab-in-adults-with-gastric-cancer-100644673","NCT07673887","A Study of ASP2138 Together With Chemotherapy and Pembrolizumab in Adults With Gastric Cancer","A Phase 3, Global, Multi-center, Double-blind, Randomized Study of ASP2138 Plus Chemotherapy (CAPOX or mFOLFOX6) With Pembrolizumab vs Placebo Plus Chemotherapy With or Without Pembrolizumab in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in Participants Whose Tumors Are HER2-negative and Claudin (CLDN) 18.2-positive","Inclusion Criteria:\n\n* Participant has histologically or cytologically confirmed gastric or GEJ adenocarcinoma.\n* Participant has radiographically confirmed, locally advanced unresectable or metastatic disease within 28 days prior to randomization.\n* Participant has predicted life expectancy \\>= 12 weeks.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a women of childbearing potential (WOCBP)\n  * WOCBP who has a negative serum pregnancy test at screening and agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention. (Note: For screening, participants with elevated serum human chorionic gonadotropin (HCG) and a demonstrated nonpregnant status through additional testing are eligible.)\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period, and at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 6 months after the final administration of study intervention.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after the final administration of study intervention.\n* Male participant must not donate sperm during the treatment period and for 6 months after the final administration of study intervention.\n* Participant has radiologically evaluable disease (measurable and\u002For non measurable) according to RECIST V1.1, per investigator assessment, \\\u003C= 28 days prior to randomization. For participants with only 1 evaluable lesion and prior radiotherapy \\\u003C= 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.\n* Participant's tumor is HER2-negative (HER2 immunohistochemistry (IHC) score 0+\u002F1+ or HER2 IHC score 2+\u002Fin situ hybridization (ISH) negative) as determined by local or central testing.\n* Participant has provided an formalin-fixed paraffin-embedded (FFPE) tumor sample which meets the requirements of the study as specified in the laboratory manual.\n* Participant has CLDN18.2-positive tumor as determined by central testing.\n* Participant has a valid programmed death-ligand 1 (PD-L1) result as determined by central testing of a tumor sample.\n* Participant with known microsatellite instability-high or mismatch repair deficient status may enroll as long as their tumor expresses PD-L1 combined positive score (CPS) \\>= 1 as determined by central IHC testing.\n* Participant has ECOG performance status 0 to 1.\n* Participant must meet all of the criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In case of multiple central laboratory data within this period, the most recent data should be used (transfusion is allowed, but posttransfusion hemoglobin \\[24 hours or later following transfusion\\] must be \\>= 9 g\u002FdL).\n\nSouth Korea Specific:\n\n* Participant is \\>= 19 years of age at the time of signing informed consent.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a WOCBP\n  * WOCBP who has a negative serum pregnancy test at screening and agrees to follow the contraceptive guidance from the time of informed consent through at least 15 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention. (Note: For screening, participants with elevated serum HCG) and a demonstrated nonpregnant status through additional testing are eligible.)\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period, and at least 15 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for at least 15 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period, and for 12 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 12 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must not donate sperm during the treatment period and for 12 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n\nJapan Specific:\n\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a WOCBP\n  * WOCBP who has a negative serum pregnancy test at screening with a medical interview and agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention. (Note: For screening, participants with elevated serum HCG and a demonstrated nonpregnant status through additional testing are eligible.)\n\nExclusion Criteria:\n\n* Participant has mixed histology or non-adenocarcinoma gastric or GEJ cancer.\n* Participant has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to randomization.\n* Participant has gastrointestinal (GI) perforation, fistulae, untreated gastric ulcers that would preclude the participant from study participation, or any arterial thromboembolic event within 6 months, or any significant GI bleeding or any significant venous thromboembolism within 3 months prior to randomization.\n* Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent\u002Frecurrent vomiting.\n* Participant has pre existing peripheral neuropathy \\> Grade 1.\n* Participant has poorly controlled hypertension.\n* Participant has significant cardiovascular disease, including any of the following:\n\n  * Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization.\n  * corrected QT (QTc) interval \\> 450 msec for male participants; QTc interval \\> 470 msec for female participants.\n  * Documented history or family history of congenital long QT syndrome.\n  * Cardiac arrhythmias requiring anti-arrhythmic medications (Exception: Participant with rate-controlled atrial fibrillation for \\> 1 month prior to randomization is eligible), obligate use of cardiac pacemaker, or a history of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes).\n* Participant has a diagnosis of immunodeficiency or has been diagnosed with an autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Participants that require replacement therapy (e.g., thyroxine (T4), insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.\n* Participant has psychiatric illness or social situations that would preclude study compliance.\n* Participant has history of another malignancy within 3 years prior to randomization, or any evidence of residual disease from a previously diagnosed malignancy. Participants with nonmelanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance\u002Fwatchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed.\n* Participant has history of (non-infectious) pneumonitis that required steroids, current pneumonitis, or has a history of interstitial lung disease.\n* Participant has known, existing uncontrolled coagulopathy. Concomitant treatment with medications that affect the coagulation cascade with an international normalized ratio (INR) \\> 2 (e.g., vitamin K antagonists) is not allowed.\n* Participant may receive low molecular weight heparin (LMWH) (such as enoxaparin and dalteparin) and direct oral anticoagulant (DOAC) for management of deep venous thrombosis (DVT).\n* Participant has a history of bleeding diathesis or recent major bleeding events (i.e. Grade \\>= 2 bleeding events 28 days prior to randomization).\n* Participant has uncontrolled intercurrent illness.\n* Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.\n* Participant is known to have human immunodeficiency virus (HIV) infection except for those with cluster of differentiation (CD) 4+ T cell counts \\>= 350 cells\u002Fmicroliter (µL) and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 12 months are eligible. NOTE: Screening for HIV infection should be conducted if indicated per local requirements.\n* Participant is known to have active hepatitis B (positive hepatitis B surface antigen \\[HBsAg\\]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements. NOTE: Screening for these infections should be conducted if indicated per local requirements.\n\n  * For participant who is negative for HBsAg, but hepatitis B core (HBc) antibody positive, an hepatitis B virus (HBV) DNA test will be performed and if positive the participant will be excluded.\n  * Participant with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results is eligible.\n  * Participant treated for HCV with undetectable viral load results is eligible.\n* Participant has a known history of a positive test for tuberculosis or known active tuberculosis infection. NOTE: Screening for these infections should be conducted per local requirements.\n* Participant has known complete dihydropyrimidine dehydrogenase (DPD) deficiency (screening for DPD deficiency should be conducted per local requirements).\n* Participant has pernicious anemia or other anemias due to vitamin B12 deficiency.\n* Participant has received prior systemic chemotherapy and\u002For immunotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, a maximum of 1 cycle of mFOLFOX6 or CAPOX with or without immunotherapy (for those participants with CPS \\>= 1) is allowed to be administered prior to randomization (Note: No dose modifications are allowed for the lead-in treatment). Participants may have received either neoadjuvant or adjuvant chemotherapy, immunotherapy, or other systemic anticancer therapies as long as they were completed at least 6 months prior to randomization and there was disease progression occurs at least 6 months after the last dose. Participant may have received treatment with herbal medications that have known antitumor activity \\> 28 days prior to randomization. NOTE: Participants must have recovered from all AEs due to previous therapies to \\\u003C= Grade 1 or baseline.\n* Participant has received systemic immunosuppressive therapy, including systemic corticosteroids \\\u003C= 7 days prior to randomization. Participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.\n* Participant has had a major surgical procedure \\\u003C= 28 days before randomization and has not fully recovered.\n* Participant has received a CLDN18.2-targeted therapy \\\u003C= 28 days or 5 half-lives (whichever is longer) prior to randomization, or participant has experienced Grade \\>= 3 GI toxicity after receiving a CLDN18.2-targeted therapy.\n* Participant has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma \\\u003C= 14 days prior to randomization and has NOT recovered from any related toxicity. A 7-day washout is permitted for palliative radiation (\\\u003C= 14 days duration time for radiotherapy) to non-CNS disease.\n* Participant has received prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \\[CTLA-4\\], OX-40, CD137) unless received in the perioperative setting.\n* Participant received a live or live-attenuated vaccine within 30 days prior to randomization. NOTE: Inactivated seasonal influenza vaccines are allowed.\n* Participant has received treatment with brivudine, sorivudine or their chemically related analogues within 28 days prior to randomization or within 5 half-lives of the drug, whichever is shorter.\n* Participant has received any investigational therapy within 28 days prior to randomization or within 5 half-lives of the investigational medicinal product (IMP), whichever is longer.\n* Participant has any condition including clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.\n* Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention.\n\nEU Specific:\n\n* Participant has known complete DPD deficiency (screening for DPD deficiency should be conducted per local requirements). All participants in the EU must be tested for DPD deficiency before receiving fluoropyrimidine-based chemotherapy, in accordance with European Society for Medical Oncology and European Medicines Agency (EMA) recommendations.",{"count":263,"type":20},570,[23],"Claudin 18.2 or CLDN18.2 is a protein found on cells in the digestive system. It is also found in some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a type of immune cell called a T cell. This \"tells\" the immune system to attack the tumor. ASP2138 is a potential treatment for people with gastric cancer (also known as stomach cancer) or gastroesophageal junction cancer (GEJ cancer). GEJ is where the tube that carries food (esophagus) joins the stomach.\n\nThis study is for people with gastric or GEJ cancer that has spread nearby (locally advanced) and is not removable by surgery (unresectable), or has spread to other parts of the body (metastatic). It is for those whose cancer is human epidermal growth factor receptor 2 (HER2)-negative and CLDN18.2-positive. HER2-negative means the cancer does not have extra HER2 protein, so medicines that target HER2 do not work and are therefore not used. CLDN18.2-positive means people have a certain amount of CLDN18.2 proteins on their cancer cells. In this study, researchers want to learn if ASP2138 given together with standard treatments (chemotherapy and pembrolizumab) help people with HER2-negative and CLDN18.2-positive gastric or GEJ cancer. The main aim is to learn how long people who are given ASP2138 with chemotherapy and pembrolizumab live without their cancer getting worse, compared with placebo given with chemotherapy with or without pembrolizumab, and if they live for longer. Placebo looks like the study treatment but does not have any medicine in it.\n\nThe main aim of this study is to check how well ASP2138 works when given together with chemotherapy and pembrolizumab compared with placebo plus chemotherapy with or without pembrolizumab.\n\nPeople aged 18 years or older with locally advanced unresectable or metastatic gastric or GEJ cancer can take part. Their tumor should be HER2-negative and CLDN18.2-positive. The study doctors will check people for any health conditions that can exclude them from taking part, interfere with the study procedures, or pose an unacceptable risk.\n\nThis is a double-blind study. That means the people and the study doctors will not know who will receive which treatment. People will be assigned to one of 2 treatment groups by chance:\n\nGroup A: People will receive ASP2138 along with chemotherapy and pembrolizumab. Group B: People will receive placebo along with chemotherapy, with or without pembrolizumab.\n\nPeople will keep receiving treatment until their cancer gets worse, they have medical problems that require stopping treatment, or a study rule says they must stop. There will be regular safety checks. People will continue to have scans of their tumor until their cancer becomes worse.",[267,268],"Gastric Adenocarcinoma","Gastroesophageal Junction (GEJ) Adenocarcinoma",[270,271,272,273],"Claudin (CLDN) 18.2","ASP2138","Advanced Unresectable or Metastatic Gastric Adenocarcinoma","Advanced Unresectable or Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma","NOT_YET_RECRUITING","2026-06-23",{"date":195,"type":54},{"date":197,"type":20},{"date":279,"type":20},"2031-02-28",{"name":60,"class":61},{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":16,"minAge":289,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":292,"conditions":293,"keywords":297,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":62},"100625664","a-study-to-learn-how-stargardt-type-eye-conditions-progress-in-children-and-adults-100625664","NCT07425574","A Study to Learn How Stargardt-type Eye Conditions Progress in Children and Adults","An Observational Study of Natural Disease Progression in Participants With Macular Dystrophies Expressing a Stargardt-type Clinical Presentation","EVOLVE","Inclusion Criteria:\n\n* Participant has a documented clinical diagnosis of macular dystrophy expressing a STGD-type clinical presentation and molecular confirmation, defined as either:\n\n  * ABCA4-associated disease: presence of biallelic (pathogenic or likely pathogenic) ABCA4 variants, or one definite disease-causing ABCA4 variant together with a typical phenotype consistent with STGD.\n  * STGD-like macular dystrophy: presence of one or more pathogenic variants in a gene known to cause macular dystrophy, as appropriate for its expected inheritance mode. Note: All genetic testing should be performed by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory or equivalent whenever possible. Acceptable documentation includes a copy of the genetic test report, laboratory certification statement, or clinical notes explicitly referencing CLIA certification. Predicted pathogenic variant of uncertain significance (VUS) that cannot be confirmed by standard laboratory criteria as certainly disease-causing (novel mutations) will be considered on a case by-case basis.\n* Participant has sufficiently clear ocular media and adequate pupillary dilation to allow for all imaging procedures.\n* Participant has intraocular pressure (IOP) both at screening and baseline of ≤ 21 mmHg measured by applanation tonometry. Note: Participant who is on topical IOP lowering treatment may also be included.\n* Participant has a spherical equivalent refractive error between + 8.00 D and - 10.00 D. Eyes with high myopia (\\> -10.00 D) are permitted only if there are no signs of myopic degenerative macular changes.\n* Participant has a BCVA ranging from 20\u002F500 to 20\u002F40 (equivalent to 15 to 70 ETDRS letters read at 1 meter)\n\n  * For participants in the \\> 20\u002F80 to ≤ 20\u002F40 BCVA range (moderate visual impairment \\[MVI\\]): presence of a visible definite or probable residual EZ on SD-OCT (no minimum residue size required) and a minimum central mean subfield retinal thickness on optical coherence tomography (OCT) ≥ 150 µm\n  * For participants in the ≥ 20\u002F500 to ≤ 20\u002F80 BCVA range (SVI): presence of a residual outer nuclear layer (ONL) within the macular OCT scan area and measurable within the Age-Related Eye Disease Study (AREDS) grading grid and no residual EZ or minimal thickness of the ONL required\n* Participant has evidence of retinal pigment epithelium (RPE) disease\u002Fdamage on SD-OCT (hypertransmission defects \\[HTDs\\]) and\u002For FAF imaging.\n* Participant has evidence of at least questionably decreased autofluorescence (QDAF) (incomplete retinal pigment epithelial and outer retinal atrophy \\[iRORA\\]), defined as mottled or speckled hypo-autofluorescence (AF) signal, mixed with or without hyper- AF, on FAF imaging. Note: At study onset, having patches of definitely decreased autofluorescence (DDAF) within the FAF image and\u002For patches of complete retinal pigment epithelial and outer retinal atrophy (cRORA) on SD-OCT ≥ 250 µm will not be a requirement for participation but will be acceptable for inclusion, so long as:\n\n  * DDAF\u002FcRORA areas are contained within the limits of the AREDS grading grid (≤ 12 disc areas), and physically distinct and separate from other areas of QDAF, DDAF and\u002For hyper-AF that may be present outside the AREDS grading grid, and\n  * the other BCVA and SD-OCT required inclusion criteria are also met.\n* Participant is able to comply with the protocol and willing to undertake all scheduled visits and assessments during the total study period.\n* Participant is deemed capable of performing reliably all tests required for participation.\n\nExclusion Criteria:\n\n* Participant has a known history of significant systemic disease (e.g., uncontrolled hepatitis, pancreatitis, cirrhosis, liver failure, uncontrolled thyroid disease or immunocompromising conditions such as human immunodeficiency virus \\[HIV\\]) that could impact ocular health or confound study assessments, based on medical history or prior clinical documentation.\n* Participant has an autoimmune condition that requires treatment with immunomodulatory therapy and\u002For biologics that cause immunosuppression.\n* Participant has a known diagnosis of diabetes mellitus with a documented hemoglobin A1c (HbA1c) value ≥ 7% 3 months prior to screening and based on available medical records. If the documented HbA1c is ≥ 7% and there is no clinical history of diabetic symptoms, diabetic retinopathy, abnormal renal function (e.g., elevated creatinine), or glycosuria noted in medical records, the participant may be enrolled.\n* Participant has a known history of any systemic or metabolic condition, or physical examination finding that may significantly affect ocular health or interfere with the interpretation of study assessments.\n* Participant has a history or evidence of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV), clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months prior to screening.\n* Participant has a history or evidence of ventricular tachyarrhythmia requiring ongoing treatment.\n* Participant has a significant cardiovascular or cerebrovascular disease, including a history of stroke within 12 months prior to screening.\n* Participant has any complicating systemic disease or active malignancy. Squamous cell carcinomas will be an exclusionary criterion if lesions are recurrent and\u002For \\> 2 cm in diameter and\u002For affect the lip or ear area. Basal cell carcinomas are permitted, provided they are not located in the immediate periocular facial region. A history of any prior malignancy is allowed if the treating physician or oncologist confirms that the participant has been free of recurrence or metastasis for at least 5 years prior to screening.\n* Participant has another known or suspected molecular diagnosis of macular or retinal disease (e.g., pathogenic mutations in other genes) that could confound interpretation of study outcomes, indicate a second concomitant retinal condition or suggest a different etiology for the macular disease.\n* Participant has evidence or history of choroidal neovascularization.\n* Participant has macular atrophy due to any cause other than a genetically or clinically confirmed diagnosis of STGD or STGD-like macular dystrophies.\n* Participant has a known diagnosis of any form of uncontrolled glaucoma (for high tension glaucoma IOP \\> 25 mmHg).\n* Participant has and\u002For is receiving treatment for thyroid eye disease.\n* Participant has diabetic retinopathy in excess of mild nonproliferative diabetic retinopathy (i.e., presents with widespread retinal microaneurysms, dot-blot hemorrhages, and cotton-wool retinal spots).\n* Participant has any other disease(s) affecting the optic nerve.\n* Participant has a history of anterior or posterior uveitis and\u002For presence of intraocular inflammation (≥ trace anterior chamber cell or flare), or history of idiopathic or autoimmune-associated uveitis in either eye. Note: A single, sporadic episode of anterior uveitis without recurrences in the past 5 years and not associated with chronic conditions that increase the likelihood of recurrence may be accepted on a case-by-case basis in consultation with the sponsor's medical monitor\u002Flead.\n* Participant has corneal or lenticular opacities impeding the visualization of the fundus and\u002For the reliable performance of the visual function tests required by the protocol.\n* Participant has sufficiently narrow iridocorneal angles contraindicating pupillary dilation that have not been previously treated with preventative laser iridotomies.\n* Participant has any other ocular disorders that could interfere with or confound visual acuity and other ocular assessments, including OCT or FAF.\n* Participant has a clinically significant epiretinal membrane or evidence of clinically significant vitreomacular traction syndrome. Note: A mild enhancement of the vitreoretinal interface seen on OCT without any alteration of the foveal profile would not be considered an exclusion criterion.\n* Participant has presence of or recurrent vitreous hemorrhages. Note: A one-time episode of a traumatic vitreous hemorrhage would not result in exclusion, so long as resolved.\n* Participant has aphakia.\n* Participant has anticipated need for cataract surgery during the study period.\n* Participant has a macular hole, evident by ophthalmoscopy and\u002For by SD-OCT examinations, or history of prior macular hole surgery.\n* Participant has a history of any of the following procedures: posterior vitrectomy, retinal detachment surgery, glaucoma filtering surgery (e.g., trabeculectomy), glaucoma drainage device implantation, selective laser trabeculoplasty, full-thickness or partial-thickness corneal transplant (e.g., Descemet's stripping endothelial keratoplasty, Descemet's stripping automated endothelial keratoplasty or Descemet's membrane endothelial keratoplasty).\n* Participant has any lesion that is considered to pose a risk of retinal detachment during the study. Any preexisting lesion may be treated to allow eligibility, but treatment must be completed at least 3 months prior to screening.\n* Participant has had any prior thermal laser or photodynamic therapy treatment in the macular region, regardless of indication. Peripheral retinal thermal laser treatments for holes, lattice degeneration, and\u002For other lesions with rhegmatogenous potential are permitted within 3 months prior to screening, subject to their potential impact on a future pars plana vitrectomy surgery.\n* Participant has had any intraocular surgery within 3 months of screening.\n* Participant has a history of intraocular metallic foreign bodies.\n* Participant has received any treatment including gene therapy, stem cell therapy, surgical implantation of prosthetic retinal chips, or any prior intravitreal treatment for any indication in either eye that may be considered to potentially interfere with the study participation or its conduct.\n* Participant is receiving concomitant treatment with any ocular or systemic medication known to be toxic to the lens, retina or optic nerve.\n\n  * Participant is using hydroxychloroquine (Plaquenil), chloroquine, pentosan polyphosphate (Elmiron), tamoxifen, chlorpromazine, thioridazine (Mellaril), isotretinoin (Accutane) or any related retina-toxic compounds at screening.\n* Participant has received therapeutic radiation in the region of the study eye.\n* Participant has had any major surgical procedure within 1 month prior to screening or anticipates having one during the study, which may interrupt study participation.\n* Participant is taking glucagon-like peptide-1 (GLP-1) receptor agonists and is unable or unwilling to stop the medication at least 4 weeks prior to screening. A history of treatment with a GLP-1 receptor agonist is allowed.\n* Participant is taking metformin and is unable or unwilling to stop this medication at least 4 weeks prior to screening. A history of treatment with metformin is allowed.\n* Participant is participating in an interventional study of a vitamin A metabolism inhibitor, a vitamin A analog\u002Fderivative, or another investigational drug product within 3 months prior to screening. After a 3 month washout period, participants can be considered for enrollment. Participation in a noninterventional study (NIS) is allowed.\n* Participant has a known or suspected hypersensitivity to eyedrops used for IOP measurement or pupil dilation.\n* Participant has any condition that makes the participant unsuitable for study participation.","6 Years",{"count":291,"type":20},90,"Macular dystrophies are a group of inherited eye conditions that affect the macula. The macula is in the center of the retina, the light sensitive part at the back of the eye. In people with macular dystrophies, some of the cells in the macula gradually stop working and may die over time. This leads to vision loss in the center of the eye. Side vision (peripheral vision) is mostly unaffected. Stargardt disease (STGD) is a type of macular dystrophy which is caused by 1 faulty gene (ABCA4). Vision loss most typically happens in childhood, but many people do not develop it until they are adults. As well as STGD, there are other macular dystrophies that look very similar to STGD but that are caused by many other different genes. Together, STGD and STGD-like conditions can be called STGD-type macular dystrophies. This is because they look the same clinically and have similar symptoms. Since different genes can cause these conditions, genetic testing is the only way to be sure which specific condition a person has.\n\nIn this study, researchers want to learn if the disease progresses in a similar way in people with STGD and STGD-like macular dystrophies. People taking part in the study will continue to manage their condition, as agreed with their own doctor. People will visit their clinic every 6 months to have various standard eye tests and imaging. The information collected will include questions about people's wellbeing, general health, medication and supplements taken, and daily activities.\n\nChildren over 6 years old and adults with STGD-type macular dystrophies may take part in this study. They will be in the study for up to 24 months (2 years). The study sponsor (Astellas) will not decide how people's condition is managed. However, the sponsor will provide instructions on when people visit their clinic and what is recorded during the study. If available, medical records, clinical and imaging data from previous visits going back 24 months will also be reviewed.",[294,295,296],"Stargardt Disease","Stargardt Macular Dystrophy","Stargardt-like Macular Dystrophy",[298,299,300,301],"Macular Dystrophies","Stargardt type","ABCA4 related STGD","STGD-like macular dystrophies",{"date":247,"type":54},{"date":304,"type":54},"2026-02-20",{"date":306,"type":20},"2028-07-31",{"name":60,"class":61},{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":16,"minAge":315,"maxAge":316,"enrollmentInfo":317,"targetDuration":4,"studyType":21,"phases":319,"briefSummary":320,"conditions":321,"keywords":324,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":343},"100513799","phase-3-a-study-of-roxadustat-to-treat-anemia-in-children-and-teenagers-with-chronic-kidney-disease-100513799","NCT05970172","A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease","A Phase 3, Open-label, Uncontrolled Study to Evaluate the Activity, Safety, Pharmacokinetics and Pharmacodynamics of Roxadustat for the Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease","Inclusion Criteria:\n\n* Participant has a diagnosis of anemia in CKD Kidney Disease Outcomes Quality Initiative stages 3 or 4 or 5. This can include participants not on dialysis or dialysis dependent (DD) participants (including hemodialysis, peritoneal dialysis and hemodiafiltration participants).\n* Participants not on dialysis must have an estimated glomerular filtration rate (Schwartz formula) of \\\u003C 60 mL\u002Fmin per 1.73 m\\^2.\n* ESA-treated participants should have a screening Hb level, assessed via HemoCue, between 10.0 and 12.0 g\u002FdL; ESA-naïve participants can have a Hb level ≤ 11 g\u002FdL.\n* Participant has a ferritin level \\> 100 ng\u002FmL or a transferrin saturation (TSAT) value \\> 20%.\n* Participant has an alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN) and total bilirubin (TBL) ≤ 1.5 x ULN at enrollment visit.\n* Participant is treated with an ESA or is ESA-naïve, where ESA status is defined as:\n\n  * ESA-treated: Participant is taking a stable dose of an ESA for at least 4 weeks prior to screening.\n  * ESA-naïve: Participant has no prior ESA exposure OR participant's total prior ESA exposure ≤ 3 weeks within the preceding 4 weeks from screening OR participant was previously treated with and discontinued an ESA ≥ 8 weeks prior to screening.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 4 weeks after final study intervention administration.\n* Female participant must agree not to breastfeed starting at screening and throughout the study and for 4 weeks post-last roxadustat dose.\n* Female participant must not donate ova starting at first administration of roxadustat and throughout the study period and for 4 weeks post-last roxadustat dose.\n* Male participants with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 4 weeks post-last roxadustat dose.\n* Male participants must not donate sperm during the treatment period and for 4 weeks post-last roxadustat dose.\n* Male participants with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 4 weeks post-last roxadustat dose.\n* Participant and\u002For participant's parent or legal guardian agrees for the participant not to participate in another interventional study while participating in the present study.\n\nExclusion Criteria:\n\n* Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.\n* Participant has any medical condition, including active, systemic or clinically significant infection which may pose a safety risk to a participant in this study, which may confound the safety or activity assessment or may interfere with study participation making the participant unsuitable for study.\n* Participant has a known or suspected hypersensitivity to roxadustat, related hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHI), or any components of the formulation used.\n* Participant has uncontrolled hypertension (defined as ≥ 95th percentile + 12 mm Hg or ≥ 140\u002F90 mm Hg \\[whichever is lower\\] for participants \\\u003C 13 years of age and ≥ 140\u002F90 mm Hg for participants ≥ 13 years of age measured 3 times at the same visit) in the 2 weeks prior to screening.\n* Participant has a known hematologic disease other than anemia secondary to renal disease,(e.g., history of sickle cell disease, sickle cell anemia, hemoglobin sickle cell disease, or hemoglobin sickle cell beta thalassemia).\n* Participant has untreated hypothyroidism.\n* Participant has severe hyperparathyroidism defined as serum parathyroid hormone (PTH) levels above 1000 pg\u002FmL intact PTH within 4 weeks of screening.\n* Participant has a functioning kidney allograft.\n* Participant has a folate or B12 or carnitine deficiency. Acceptable if treated to normal values within 4 weeks of screening.\n* Participant has a known active malignancy or malignancy within 18 months before the screening visit. Radiation or chemotherapy must be completed at least 12 months before the screening visit.\n* Participant has a scheduled living donor organ transplantation date within 12 weeks of screening. If participant becomes eligible for a kidney transplant during study conduct, the participant should be discontinued.\n* Participant has a whole blood or packed red blood cells (pRBC) transfusion during the 8 weeks prior to screening.\n* Participant has any current condition leading to active significant blood loss in the past 4 weeks.\n* Participant has a diagnosis of hemolytic uremic syndrome within 12 weeks prior to screening.\n\n  * Participant who has a previous diagnosis of atypical hemolytic syndrome must be relapse-free (stable hemoglobin (Hb), normal platelet count, normal serum lactate dehydrogenase, and normal haptoglobin level) for more than 12 weeks prior to screening.\n* Participant has a history of chronic liver disease, including comorbidity with autosomal recessive polycystic kidney disease, cystinosis, and primary hyperoxaluria.\n* Participant had an episode of peritonitis within 30 days of screening.\n* Participant has active inflammation such as glomerulonephritis flare (i.e., lupus nephritis, immunoglobulin A (IgA) nephritis, rapidly progressive glomerulonephritis, membranoproliferative glomerulonephritis, antineutrophil cytoplasmic antibodies vasculitis) requiring pulse corticosteroid treatment or induction treatment with an immunosuppressive agent (i.e., cyclophosphamide, rituximab, or another monoclonal antibody) within 6 weeks of screening visit. Receipt of monoclonal antibody or biologic for maintenance treatment of underlying condition is acceptable.\n* Participant has a known history of human immunodeficiency virus infection.\n* Participant has rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or is allergic to peanut or soya.","2 Years","17 Years",{"count":318,"type":20},100,[23],"Roxadustat is a licensed medicine to treat anemia in adults with chronic kidney disease (CKD). Anemia is a low level of red blood cells. Current treatment for anemia is to have injections of medicines called erythropoietin stimulating agents (also known as ESAs) to help the bone marrow make more red blood cells. These are often given together with iron. This treatment is also available to children and teenagers with CKD. However, there are some safety concerns with ESAs. Also, as roxadustat is taken orally, this may be another option for treating anemia in children and teenagers with CKD. In this study, children and teenagers with CKD and anemia will take roxadustat for up to 52 weeks to treat their anemia.\n\nThe main aim of the study is to learn how roxadustat affects anemia in children and teenagers with CKD.\n\nThis is an open-label study which means the children and teenagers in the study and the clinic staff know they will be taking roxadustat. In this study, the children and teenagers with CKD who need treatment for anemia can take part. Those currently being treated with an ESA will be switched to roxadustat. Those who have not been treated with an ESA can start on roxadustat straight away. All children and teenagers in the study will take roxadustat 3 times a week for up to 52 weeks (1 year). They will start on a fixed dose of roxadustat for 4 weeks. Blood samples will be taken regularly to check hemoglobin levels. The roxadustat dose may be changed if the blood levels of hemoglobin are too high, too low, or change too quickly. After 4 weeks the dose may be changed, if needed, to keep blood levels of hemoglobin in the blood to just below the normal range.\n\nFirstly, teenagers will take roxadustat. 10 teenagers will take their fixed dose of roxadustat for 4 weeks. They will give blood samples to help the researchers work out the most suitable dose for the rest of the teenagers in the study. When the rest of the teenagers start taking roxadustat at the most suitable dose for teenagers, 10 children will take roxadustat for 4 weeks. These 10 children will give blood samples to help the researchers work out the most suitable dose for the rest of the children in the study. Then, the rest of the children will take roxadustat at the most suitable dose for children.\n\nThere will be many clinic visits during the study. Overnight hospital stays are not expected. There will be 1 visit every 2 weeks for the first 4 weeks of taking roxadustat, then every 4 weeks until the end of treatment. Finally there is 1 visit 4 weeks after treatment has finished.\n\nDuring most visits, the children and teenagers will have their vital signs checked (blood pressure, body temperature and heart rate). Fluid status (how much water is in the body) will also be checked for those who need dialysis. The children and teenagers will also have blood tests and the study doctors will check for any medical problems. The children and teenagers will have a medical examination before their first dose of roxadustat and again at about 24-week (6-month) and 52-week (13-month) visits. They will have an electrocardiogram (ECG) before their first dose of roxadustat and again at the 12-week, 24-week, 36-week, and 52-week visit. They will also have urine tests at the 4-week, 24-week and 52-week visits. At the 52-week visit, the children and teenagers will also have blood tests for hemoglobin and iron levels. The study doctors will also check for any medical problems.",[322,323],"Chronic Kidney Disease","Renal Anemia",[325,326,327,323,328,322,329,330,331,332,167,333,334],"Roxadustat","ASP1517","Pediatric","Chronic renal failure","Renal Insufficiency, Chronic","Anemia","Open-label","Uncontrolled","Pharmacokinetics","Pharmacodynamics","2026-06-18",{"date":337,"type":54},"2026-06-22",{"date":339,"type":54},"2024-01-16",{"date":341,"type":20},"2027-10-30",{"name":60,"class":61},47,{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":21,"phases":353,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":373},"100615083","phase-1-a-study-of-asp2998-given-by-itself-and-given-with-standard-therapies-in-people-with-solid-tumors-100615083","NCT07287995","A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors","A Phase 1b\u002F2 Study of ASP2998 as Monotherapy and in Combination With Standard Therapies in Participants With Locally Advanced Unresectable or Metastatic Solid Tumors","Inclusion Criteria:\n\n* For the ASP2998 monotherapy dose escalation (excluding urothelial and non-small cell lung cancer (NSCLC) tumor-specific backfill participants), the following criteria apply:\n\n  * Participant has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumors.\n  * Participant has progressed on, is ineligible for, or has refused all available standard therapies (no limit to the number of prior treatment regimens).\n  * Prior exposure to TROP2, stimulator of interferon genes (STING) agonist or topoisomerase I (TopI) directed therapy is allowed.\n  * Participant must have one of the following malignancies: Urothelial carcinoma, NSCLC (nonsquamous cell histology), Gastric\u002F gastroesophageal junction (GEJ) cancer, Breast cancer (human epidermal growth factor receptor 2 \\[HER2\\]-negative; local testing for HER2 status is acceptable).\n  * For all tumor types, any component of neuroendocrine histology is ineligible.\n* For the ASP2998 NSCLC second line (2L)+ Monotherapy Dose Expansion Cohort(s) (including the tumor-specific backfill participants from the monotherapy dose escalation), the following criteria apply:\n\n  * Participant has locally advanced unresectable or metastatic NSCLC with known programmed cell death-1 (PD-L1) status, without actionable oncogenic alteration (AGA), according to local testing.\n  * Participant must have histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic NSCLC that has progressed on or after receiving platinum-based chemotherapy and\u002For checkpoint inhibitors according to local\u002Fregional standard of care.\n  * Participant is also eligible if there is disease progression within 12 months of receiving neoadjuvant or adjuvant therapy for resectable disease.\n  * Participant must be eligible to receive treatment in 2L+ setting.\n  * Participant must have had no more than 3 prior lines of therapy.\n  * No prior exposure to TROP2, STING agonist or TopI directed therapy is allowed.\n* For the ASP2998 Urothelial Carcinoma Monotherapy Dose Expansion Cohort(s) (including the tumor-specific backfill participants from the monotherapy dose escalation), the following criteria apply:\n\n  * Participant must have histologically or cytologically confirmed diagnosis of urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter or urethra) in locally advanced unresectable or metastatic setting that has progressed on a combination of enfortumab vedotin and pembrolizumab according to local\u002Fregional standard of care. Participant with urothelial carcinoma (transitional cell) with \\\u003C 50% squamous differentiation or mixed cell types is eligible.\n  * Participant is also eligible if there is disease progression within 12 months of receiving adjuvant or neoadjuvant therapy for resectable disease.\n  * Participant must be eligible to receive treatment in 2L+ setting.\n  * Participant must have had no more than 3 prior lines of therapy.\n  * No prior exposure to TROP2, STING agonist or TopI directed therapy is allowed.\n* For ASP2998 combination therapy (including the tumor-specific backfill participants from the combination therapy dose escalation), the following criteria apply for the NSCLC first line (1L) ASP2998 + Pembrolizumab + Carboplatin Dose Escalation and Expansion Cohort(s):\n\n  * Participant has locally advanced unresectable or metastatic NSCLC (adenocarcinoma only, no mixed histology allowed), with known PD-L1 status, without AGA, according to local testing.\n  * Participant is also eligible if there is disease progression \\> 12 months after completing adjuvant or neoadjuvant therapy for resectable disease.\n  * Participant has not received prior therapy for metastatic disease.\n  * No prior exposure to TROP2, STING agonist or TopI directed therapy is allowed in dose escalation or dose expansion.\n* For ASP2998 combination therapy (including the tumor-specific backfill participants from the combination therapy dose escalation), the following criteria apply for the Urothelial Carcinoma 1L ASP2998 + Pembrolizumab + Enfortumab Vedotin Dose Escalation and Expansion Cohort(s):\n\n  * Participant must have histologically or cytologically confirmed diagnosis of urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter or urethra) in locally advanced unresectable or metastatic setting. Participant with urothelial carcinoma (transitional cell) with \\\u003C 50% squamous differentiation or mixed cell types is eligible.\n  * Participant is also eligible if there is disease progression \\> 12 months after completing adjuvant or neoadjuvant therapy for resectable disease.\n  * Participant has not received prior therapy for metastatic disease.\n  * No prior exposure to TROP2, STING agonist or TopI directed therapy is allowed in dose escalation or dose expansion.\n* For ASP2998 combination therapy (including the tumor-specific backfill participants from the combination therapy dose escalation), the following criteria apply for the NSCLC 2L+ ASP2998 + Pembrolizumab Dose Escalation Cohort(s):\n\n  * Participant has locally advanced unresectable or metastatic NSCLC with known PD-L1 status, without AGA, according to local testing.\n  * Participant has progressed on or after receiving platinum-based chemotherapy and\u002For checkpoint inhibitors according to local\u002Fregional standard of care.\n  * Participant is also eligible if there is disease progression within 12 months of receiving neoadjuvant or adjuvant therapy for resectable disease.\n  * Participant may be eligible to receive treatment in 2L+ setting.\n  * Participant must have had no more than 3 prior lines of therapy.\n  * Prior exposure to TROP2, STING agonist or TopI directed therapy is allowed.\n* For ASP2998 combination therapy (including the tumor-specific backfill participants from the combination therapy dose escalation), the following criteria apply for the Urothelial Carcinoma 2L+ ASP2998 + Pembrolizumab Dose Escalation Cohort(s):\n\n  * Participant must have histologically or cytologically confirmed diagnosis of urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter or urethra) in locally advanced unresectable or metastatic setting that has progressed on a combination of enfortumab vedotin and pembrolizumab according to local\u002Fregional standard of care. Participant with urothelial carcinoma (transitional cell) with \\\u003C 50% squamous differentiation or mixed cell types is eligible.\n  * Participant is also eligible if there is disease progression within 12 months of receiving adjuvant or neoadjuvant therapy for resectable disease.\n  * Participant must be eligible to receive treatment in 2L+ setting.\n  * Participant must have had no more than 3 prior lines of therapy.\n  * Prior exposure to TROP2, STING agonist or TopI directed therapy is allowed.\n* For ASP2998 combination therapy (including the tumor-specific backfill participants from the combination therapy dose escalation), the following criteria apply for the Urothelial Carcinoma 2L+ ASP2998 + Enfortumab Vedotin Dose Escalation Cohort(s):\n\n  * Participant must have histologically or cytologically confirmed diagnosis of urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter or urethra) in locally advanced unresectable or metastatic setting that has progressed on a combination of enfortumab vedotin and pembrolizumab according to local\u002Fregional standard of care. Participant with urothelial carcinoma (transitional cell) with \\\u003C 50% squamous differentiation or mixed cell types is eligible.\n  * Participant is also eligible if there is disease progression within 12 months of receiving adjuvant or neoadjuvant therapy for resectable disease.\n  * Participant must be eligible to receive treatment in 2L+ setting.\n  * Participant must have had no more than 3 prior lines of therapy.\n  * Prior exposure to TROP2, STING agonist or TopI directed therapy is allowed.\n* Participant has a predicted life expectancy ≥ 12 weeks.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participant has at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Participant's adverse events (AEs) (excluding alopecia) from prior anticancer therapy have improved to Grade 1 or baseline within 14 days prior to the first dose of study intervention.\n* Participant has adequate organ function as indicated by laboratory values (If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 14 days after any blood transfusion.)\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * WOCBP who has a negative serum pregnancy test and confirmed not pregnant by medical interview at screening and agrees to follow the contraceptive guidance from the time of informed consent through 7 months after final study intervention administration.\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 7 months after final study intervention administration.\n* Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 7 months after final study intervention administration.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 4 months after final study intervention administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 4 months after final study intervention administration.\n* Male participant must not donate sperm during the treatment period and for 4 months after final study intervention administration.\n* Participant agrees not to participate in another interventional study while receiving study intervention in the present study\u002Fparticipating in the present study (participant who is currently in the follow-up period of an interventional clinical study is allowed).\n\nExclusion Criteria:\n\n* Participant weighs \\\u003C 40 kg during screening.\n* Participant has known active central nervous system (CNS) metastases. NOTE: A participant with CNS metastases that have been treated with surgery and\u002For radiation therapy, who is no longer taking pharmacologic doses of glucocorticoids and is neurologically stable, is eligible. Prophylactic use of anticonvulsants is permitted.\n* Participant has any of the following:\n\n  * Any history of recurrent Grade 3 AEs\u002F immune-related AEs (irAEs) or history of Grade 4 irAEs related to prior anticancer therapy.\n  * Recurrent Grade 3 or Grade 4 toxicities related to prior anticancer therapy not improved to Grade ≤ 1 or baseline per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 or higher at least 28 days prior to initiating screening. NOTE: Participant with chronic, stable Grade ≤ 2 toxicities is eligible if the toxicity has not worsened beyond Grade 2 for at least 3 months prior to C1D1 and is managed with standard of care treatment, and is considered by the investigator to be related to prior anticancer therapy. However, a participant who meets other exclusion criteria will be excluded from the study regardless of the above provisions.\n* Participant has active or prior autoimmune or inflammatory disorders requiring systemic anti-inflammatory or immunosuppressive therapy within the past 3 years. Participants with type 1 diabetes mellitus or endocrinopathies stably maintained on appropriate replacement therapy will not be excluded.\n* Participant has uncontrolled diabetes mellitus. For cohorts receiving enfortumab vedotin, uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) of ≥ 8% or HbA1c of 7% to \\\u003C 8% with associated diabetes symptoms (polyuria or polydipsia).\n* Participant has leptomeningeal disease as a manifestation of the current malignancy.\n* Participant has a known additional malignancy that requires active treatment, with the exception of any of the following:\n\n  * Locally curable malignancies that have been apparently cured with no recurrence in the past 2 years.\n  * Adequately treated stage I cancer from which the participant is currently in remission and has been in remission for ≥ 2 years.\n  * Any other cancer from which the participant has been disease-free for ≥ 5 years.\n* Participant has a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of first administration of study intervention. Inhaled or topical steroids and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* Participant has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus (HAV) immunoglobulin M (IgM) positive, but testing for hepatitis A viral load in screening is not required), hepatitis B (hepatis B virus (HBV) (hepatitis B surface antigen positive, or HBV DNA positive if HBsAg is negative and anti-HBs and\u002For anti-HBc positive)), or hepatitis C (HCV antibody positive, confirmed by HCV RNA). NOTE: screening for these infections should be conducted per local requirements.\n* Participant has a known history of human immunodeficiency virus (HIV) infection with acquired immunodeficiency syndrome (AIDS)-related complications. HIV testing will be conducted per local requirements.\n* Participant has clinically significant cardiac disease, defined as any of the following:\n\n  * Clinically significant cardiac arrhythmias including bradyarrhythmia which are poorly controlled. Rate-controlled atrial fibrillation is permitted.\n  * Congenital long QT syndrome.\n  * corrected QT interval by Fridericia (QTcF) ≥ 470 msec at screening. Electrocardiograms (ECGs) will be performed in triplicate during screening; the average of the triplicate readings will be used in the calculation of QTc. If the QTc is prolonged in a participant with a pacemaker or a right sided bundle branch block, the participant may be enrolled. Participant with a left sided bundle branch block will be excluded.\n  * History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II or left ventricular ejection fraction (LVEF) measurement of \\\u003C 50% at baseline. Participant must not have had unstable angina (symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months.\n  * Uncontrolled hypertension, defined as systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg that has been confirmed by 2 successive measurements, despite optimal medical management.\n  * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before start of study intervention.\n* Participant has a history of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis, has current Grade ≥ 1 ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening. Participant with previously diagnosed Grade 1 radiation pneumonitis is allowed to be screened for the study. Radiation pneumonitis must be confined to the previously irradiated area of the lung and completely resolved. However, any participant with a history of radiation pneumonitis that required treatment (e.g., steroid) will be excluded, regardless of resolution.\n* Participant has inadequate pulmonary reserve due to pulmonary, heart or other disease.\n* Participant has a confirmed oxygen saturation (SpO2) \\\u003C 92% at screening.\n* Participant requires chronic oxygen supplementation therapy inclusive of noninvasive ventilation or bilevel positive airway pressure.\n* Participant has evidence of structural compromise to the trachea for any reason, including underlying malignancy.\n* Participant has had major surgery within 4 weeks prior to first dose of study intervention.\n* Participant currently has or has a history of Grade 2 or higher eye disorder, as per NCI-CTCAE v5.0 or higher.\n* Participant is at a significant risk of bleeding due to medical condition(s) or use of anticoagulants, or has a history of life-threatening bleeding (e.g., intracranial bleeding).\n* Participant has current peripheral neuropathy Grade 2 or higher (specific for enfortumab vedotin or carboplatin-containing cohorts only).\n* Participant has a history of Grade 2 or higher hearing loss (specific for the carboplatin-containing cohort only).\n* Participant has received prior TROP2 targeting agents, STING agonists or TopI inhibitor (exception: dose escalation cohorts in monotherapy and 2L+ combination therapy).\n* Participant has received prior immuno-oncology anticancer therapy within 6 weeks prior to the first dose of study intervention. Participant has received any other prior anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study intervention.\n* Participant has received prior radiation therapy within 14 days of the first dose of study intervention. Participant must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (≤ 3 weeks of radiotherapy) to non-CNS disease.\n* Participant has an active infection requiring intravenous antibiotics within 14 days prior to study intervention.\n* Participant is expected to require another form of anticancer therapy while on study intervention.\n* Participant is receiving anticoagulants (vitamin K antagonists or direct oral anticoagulants) or antiplatelet agents. Low dose aspirin is allowed.\n* Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study intervention.\n* Participant has any condition that makes the participant unsuitable for study participation.\n* Participant has a known or suspected hypersensitivity to study intervention or any components of the formulation used.\n* Participant has history of life-threatening (anaphylaxis) hypersensitivity reactions to monoclonal antibodies, bispecifics, immunomodulatory drugs or antibody-drug conjugates (ADCs).\n* Participant with severe or very severe COPD based on Global Initiative for Obstructive Lung Disease (GOLD) criteria.\n* Participant with active hemoptysis within 4 weeks of study enrollment.\n* Participant with an airway stent.\n* Participant with endobronchial tumor or tumor involvement of the airways.",{"count":352,"type":20},428,[73,74],"Specific proteins found in tumors help the tumors spread and grow. People with solid tumors often have a protein called TROP2 in their tumor. ASP2998 is being developed to attach to TROP2 and then attack the tumor cells in people with solid tumors. ASP2998 will either be given by itself, or given together with one or more of standard cancer treatments pembrolizumab, carboplatin, and enfortumab vedotin.\n\nThis is an early development study to collect information about ASP2998 in people with solid tumors. In this study ASP2998 will be given to humans for the first time. Early development studies are mostly about safety, but also to find the most suitable dose. Other aims are to check if ASP2998 shows signs of reducing tumor growth, to learn how the body processes ASP2998, and to check if there are changes either in the TROP2 protein or in the immune system.\n\nThe main aim of the study is to check the safety of ASP2998 when given by itself and given with the standard cancer treatments, and how well it is tolerated.\n\nPeople in this study will be adults with locally advanced, unresectable or metastatic solid tumors. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. People's cancer came back or became worse after previous treatment or they couldn't receive treatment. Some people who had previously refused treatment may be able to take part. This will depend on which study treatment they receive.\n\nPeople will either have cancer in the bladder lining (urothelial cancer), non-small cell lung cancer (NSCLC), gastric cancer or cancer where the food pipe joins the stomach (gastroesophageal cancer, or GEJ), or certain types of breast cancer.\n\nPeople cannot take part if the cancer cells have spread to the thin tissue covering the brain and spinal cord (leptomeningeal disease), have symptoms of cancer in the brain or nervous system, or need medicines to suppress their immune system.\n\nIn this study, ASP2998 will be given to humans for the first time. ASP2998 will either be given by itself, or given together with one or more of standard cancer treatments pembrolizumab, carboplatin and enfortumab vedotin. The standard cancer treatment given will depend on which cancer people have.\n\nThe study will have 2 parts.\n\nIn Part 1, different small groups of people will receive lower to higher doses of ASP2998 given by itself or together with one or more of the standard cancer treatments. Any medical problems will be recorded for each dose. This is done to find suitable doses of ASP2998 to use in Part 2.\n\nIn Part 2, other different small groups will receive suitable doses of ASP2998 worked out from Part 1. ASP2998 will either be given by itself or given together with one or more of the standard cancer treatments. This part will also check how each type of cancer responds to ASP2998 when given by itself or together with the standard cancer treatments.\n\nIn both parts of the study, safety checks will be done at each visit, and the doctors will continue to check for medical problems throughout the study. ASP2998 will be given slowly through a tube into a vein (infusion). People will continue to receive ASP2998 until their cancer gets worse, they can't tolerate ASP2998, they start other cancer treatment, they or the doctor decides the person should stop receiving ASP2998.",[356],"Locally Advanced or Metastatic Malignant Solid Tumors",[358,167,359,46,110,360,361,362,363,333,364],"ASP2998","Tolerability","Carboplatin","Non-small cell lung cancer","Gastroesophageal junction cancer","Breast cancer","Urothelial carcinoma","2026-06-09",{"date":367,"type":54},"2026-06-10",{"date":369,"type":54},"2026-02-05",{"date":371,"type":20},"2029-06-30",{"name":60,"class":61},7,{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":21,"phases":383,"briefSummary":384,"conditions":385,"keywords":386,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":393},"100467347","phase-1-a-study-of-asp2138-given-by-itself-or-given-with-other-cancer-treatments-in-adults-with-stomach-cancer-gastroesophageal-junction-cancer-or-pancreatic-cancer-100467347","NCT05365581","A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer","A Phase 1\u002F1b Study of ASP2138 as Monotherapy and in Combination With Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination With mFOLFIRINOX in Participants With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression","Inclusion Criteria (IC):\n\n* Participant is considered an adult according to local regulation at the time of signing the informed consent form (ICF).\n* Female participant is not pregnant, confirmed by serum pregnancy test \\&vmedical evaluation by interview \\& at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final study intervention administration.\n* Female participant must agree not to breastfeed starting at screening \\& throughout the study period \\& for 6 months after the final study intervention administration.\n* Female participant must not donate ova starting at screening \\& throughout the study period \\& for 6 months after the final study intervention administration.\n* Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period \\& for 6 months after the final study intervention administration.\n* Male participant must not donate sperm during the treatment period \\& for 6 months after the final study intervention administration.\n* Male participant with pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period \\& for 6 months after the final study intervention administration.\n* Participant's tumor sample is positive for claudin (CLDN)18.2 expression by central immunohistochemistry (IHC) testing.\n* Participant has radiographically-confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to the first dose of study intervention.\n* Participant has at least 1 measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 28 days prior to the first dose of study intervention. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Participant has QT interval by Fredericia (QTcF) =\\\u003C 470 msec.\n* Participant agrees not to participate in another interventional study while receiving study Intervention in the present study.\n* Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participant has predicted life expectancy \\>= 12 weeks.\n* Participant must meet all of criteria based on laboratory tests within 7 days prior to the first dose of study Intervention. In case of multiple laboratory data within this period, the most recent data should be used. If a participant has received a recent blood transfusion, the laboratory tests must be obtained \\>= 1 week after any blood transfusion.\n\nMonotherapy Disease specific Criteria (MDSC): Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed metastatic, locally advanced unresectable gastric\u002Fgastroesophageal junction (GEJ) adenocarcinoma.\n* Escalation: Participant with gastric\u002FGEJ adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).\n\n  * Unique to South Korea: Participant with gastric\u002FGEJ adenocarcinoma who has refused standard approved therapies is not allowed.\n* Expansion: Participant with gastric\u002FGEJ adenocarcinoma must have received no more than 3 prior lines of systemic chemotherapy treatment.\n\n  * Unique to EU: Expansion: Participant with gastric\u002FGEJ adenocarcinoma must have received at least first-line standard therapies in the metastatic setting, must have received ramucirumab treatment if eligible \\& where ramucirumab is available, \\& no more than 3 prior lines of systemic chemotherapy treatment.\n\nMDSC: Pancreatic Cancer\n\n* Participant has histologically or cytologically confirmed metastatic pancreatic adenocarcinoma.\n* Escalation: Participant with pancreatic adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).\n\n  * Unique to South Korea: Participant with pancreatic adenocarcinoma who has refused standard approved therapies is not allowed.\n* Expansion: Participants with pancreatic adenocarcinoma must have received no more than 2 prior lines of systemic chemotherapy treatment.\n\nNote: Participants with locally advanced unresectable pancreatic adenocarcinoma will not be admitted in monotherapy arms.\n\n* Unique to EU: Participant with pancreatic adenocarcinoma must have received at least first-line standard therapies in the metastatic setting \\& no more than 2 prior lines of systemic chemotherapy treatment.\n\nFor all participants in combination therapy (CT) administration:\n\n* If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 1 week after any blood transfusion.\n\nCombination Therapy Disease-specific (CTDS) IC: ASP2138 in Combination with Pembrolizumab \\& mFOLFOX6 as First-line Therapy in Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed diagnosis of gastric\u002FGEJ adenocarcinoma.\n* Participant has metastatic or locally advanced unresectable gastric\u002FGEJ adenocarcinoma.\n* Participant with gastric\u002FGEJ adenocarcinoma has progressed \\& must not have been previously treated for metastatic disease with either chemotherapy or prior checkpoint inhibitor therapy.\n* Participant has a human epidermal growth factor receptor 2 (HER2)-negative tumor per local testing.\n* For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 9 months after final study intervention.\n\n(Unique to South Korea: For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 15 months after final study intervention for women \\& 12 months after final study intervention for men).\n\nUnique to EU:\n\n* Participant must have a PD-L1 CPS ≥ 1.\n\nCTDS IC: ASP2138 in Combination with Ramucirumab \\& Paclitaxel as Second-line Therapy in Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed diagnosis of gastric\u002FGEJ adenocarcinoma.\n* Participant has metastatic or locally advanced unresectable gastric\u002FGEJ adenocarcinoma.\n* Participant with gastric\u002FGEJ adenocarcinoma must have previously received 1 line of systemic chemotherapy treatment (i.e., documented objective radiological or clinical disease progression after first line platinum \\& fluoropyrimidine treatment in the metastatic setting or disease progression during or within 4 months of the last dose of perioperative treatment.\n* For combination therapy with paclitaxel, female participant must follow contraception guidelines from time of informed consent through at least 7 months after final study intervention.\n\nCTDS IC: ASP2138 in Combination with mFOLFIRINOX as First-line Therapy in Pancreatic Cancer\n\n* Participant has histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.\n* Participant has confirmed metastatic or locally advanced unresectable pancreatic adenocarcinoma.\n* Participant has pancreatic adenocarcinoma, has progressed \\& must not have received prior systemic anticancer therapy for their advanced disease. However, participants may have received either neoadjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as they were completed at least 6 months prior to enrollment and without disease progression or recurrence.\n* For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 9 months after final study intervention.\n\n(Unique to South Korea: For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 15 months after final study intervention for women \\& 12 months after final study intervention for men).\n\nJapan \\& Korea Specific:\n\nFor All Participants in ASP2138 in Combination with Pembrolizumab \\& CAPOX:\n\n\\- If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 1 week after any blood transfusion.\n\nCTDS IC: ASP2138 in Combination with Pembrolizumab \\& CAPOX as First-line Therapy in Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed diagnosis of gastric\u002FGEJ adenocarcinoma.\n* Participant has metastatic or locally advanced unresectable gastric\u002FGEJ adenocarcinoma.\n* Participant with gastric\u002FGEJ adenocarcinoma must not have been previously treated for metastatic disease with either chemotherapy or prior checkpoint inhibitor therapy.\n* Participants have a HER2-negative tumor per local testing.\n* For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 9 months after final study intervention.\n\nExclusion Criteria (EC):\n\n* Participant has received other investigational agents, or antineoplastic therapy including other immunotherapy or devices concurrently or within 21 days or 5 times the half-life, whichever is shorter, prior to first dose of study intervention administration.\n* Participant has any condition which makes the participant unsuitable for study participation.\n* Participant has known immediate or delayed hypersensitivity or contraindication to any component of study intervention.\n* Participant has had prior severe allergic reaction or intolerance to known ingredients of ASP2138 or other antibodies, including humanized or chimeric antibodies.\n* Participant weighs \\\u003C 40 kg.\n* Participant has received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to first dose of study intervention. Participant using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single daily dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast use are allowed.\n* Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent\u002Frecurrent vomiting.\n* Participant has significant gastric bleeding \\&\u002For untreated gastric ulcers that exclude the participant from participation.\n* Participant has symptomatic CNS metastases or participant has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Participants with previously treated CNS metastases are eligible, if they are clinically stable \\& have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study intervention \\& are not requiring immunosuppressive doses of systemic steroids (\\> 10 mg per day of prednisone or equivalent) for longer than 2 weeks.\n* Participant is known to have HIV infection. However, participants with cluster of differentiation (CD4) + T cell counts \\>= 350 cells\u002FµL \\& no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 6 months are eligible.\n* Participant is known to have active hepatitis B (positive hepatitis B surface antigen \\[HBsAg\\]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements.\n\n  * For participant who is negative for HBsAg, but hepatitis B core antibody (HBc Ab) positive, a hepatitis B virus deoxyribonucleic acid test will be performed \\& if positive the participant will be excluded.\n  * Participant with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test results are eligible.\n  * Participant treated for HCV with undetectable viral load results are eligible\n* Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.\n* Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study intervention.\n* Participant has active autoimmune disease that has required systemic immunosuppressive treatment within the past 1 month prior to the start of study intervention.\n* Participant has a clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.\n* Participant has psychiatric illness or social situations that would preclude study compliance.\n* Participant has had a major surgical procedure 28 days before start of study intervention \\& has not fully recovered.\n* Participant has received radiotherapy metastatic or for locally advanced unresectable gastric\u002FGEJ or metastatic pancreatic adenocarcinoma 14 days prior to start of study intervention \\& has NOT recovered from any related toxicity.\n* Participant has another malignancy for which treatment is required.\n* Participant who has received CLDN18.2-targeted therapy (e.g., zolbetuximab or chimeric antigen receptor CLDN18.2-specific T cells) prior to first dose of study intervention administration is not eligible for dose escalation cohorts. However, a participant who has received CLDN18.2-targeted therapy greater than 28 days or 5 half-lives (whichever is longer) prior to first dose study intervention administration is eligible for dose expansion cohorts only, with the exception of participants who have experienced Grade \\>= 3 gastrointestinal toxicity after receiving an CLDN18.2-targeted therapy.\n* Participant has a history or complication of interstitial lung disease.\n\nChina Specific:\n\nParticipant who has received treatment with herbal medications that have known antitumor activity within 28 days prior to first dose of study treatment.\n\nFor all participants in CT administration:\n\n* Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention (i.e., pembrolizumab \\& mFOLFOX6 \\[all components\\], ramucirumab \\& paclitaxel or mFOLFIRINOX \\[all components\\]).\n* For 5 FU (fluorouracil): Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency.\n* Participants who have received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to the first dose of study intervention are generally excluded; however, participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single daily dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast or for chemotherapy (as part of CT administration) are allowed.\n* Participant is known to have HIV infection.\n* NOTE: Differing from monotherapy administration, participants with CD4+ T cell counts ≥ 350 cells\u002FµL \\& no history of AIDS-defining opportunistic infections within the past 6 months remain ineligible.\n* Participant has had uncontrolled high blood pressure within 6 months prior to the first dose of study intervention (Unique to EU: high blood pressure Stage 2 is defined as ≥ 140\u002F90 mmHg).\n* Participant has a history of ascites requiring drainage more than twice in the past 7 days.\n\nCTDS EC: ASP2138 in Combination with Pembrolizumab \\& mFOLFOX6 as First-line Therapy in Gastric\u002FGEJ Cancer:\n\n* Participant has history of (non-infectious) pneumonitis that required steroids, current pneumonitis, or has a history of interstitial lung disease.\n* Participant received live-virus vaccination within 30 days prior to the first dose of study intervention.\n* Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention or has been diagnosed with an autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Patients that require replacement therapy (e.g., thyroxine \\[T4\\], insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.\n\nCTDS EC: ASP2138 in Combination with Ramucirumab \\& Paclitaxel as Second-line Therapy in Gastric\u002FGEJ Cancer:\n\n* History of cerebrovascular accident or transient ischemic attack within 6 months prior to study intervention.\n* Participant has significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study intervention.\n* Participant has evidence of a bleeding diathesis or significant coagulopathy.\n* Participant has initiated new treatment with medications that affect the coagulation cascade with an INR ≥ 2 such as vitamin K antagonists, heparins \\& direct thrombin inhibitors or the use of factor Xa inhibitors within 28 days prior to the start of study intervention.\n\nNote: If the participant started receiving such medications more than 28 days prior to the start of study intervention \\& needs to continue, this is allowed. However, new anticoagulation medications may not be initiated within 28 days prior to the start of study intervention.\n\nJapan \\& Korea Specific:\n\nFor All Participants in ASP2138 in Combination with Pembrolizumab \\& CAPOX:\n\n* Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention (i.e., pembrolizumab \\& CAPOX \\[all components\\]).\n* Participants who have received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to the first dose of study intervention are generally excluded, however, participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast or for chemotherapy (as part of CT administration) are allowed.\n* Participant is known to have HIV infection.\n* NOTE: Differing from monotherapy administration, participants with CD4+ T cell counts ≥ 350 cells\u002FμL \\& no history of AIDS-defining opportunistic infections within the past 6 months remain ineligible.\n* Participant has had uncontrolled high blood pressure within 6 months prior to the first dose of study intervention.\n* Participant has a history of ascites requiring drainage more than twice in the past 7 days.\n* Participant has known DPD deficiency.\n\nCTDS EC:\n\nASP2138 in Combination with Pembrolizumab \\& CAPOX as First-line Therapy in Gastric\u002FGEJ Cancer:\n\n* Participant has history of (noninfectious) pneumonitis that required steroids, current pneumonitis, or has a history of interstitial lung disease.\n* Participant received live-virus vaccination within 30 days prior to the first dose of study intervention.\n* Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention or has been diagnosed with an autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Participants who require replacement therapy (e.g., thyroxine \\[T4\\], insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.",{"count":382,"type":20},398,[73],"Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune cell called a T-cell. This \"tells\" the immune system to attack the tumor. ASP2138 is a potential treatment for people with stomach cancer, gastroesophageal junction cancer (GEJ cancer) or pancreatic cancer. GEJ is where the tube that carries food (esophagus) joins the stomach. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. In this study, ASP2138 will either be given by itself, or given together with standard treatments for gastric, GEJ and pancreatic cancer. Pembrolizumab and mFOLFOX6, and ramucirumab and paclitaxel are standard treatments for gastric and GEJ cancer. mFOLFIRINOX is a standard treatment for pancreatic cancer. This information will help find a suitable dose of ASP2138 given by itself and together with the standard cancer treatments and to check for potential medical problems from the treatments.\n\nThe main aims of the study are:\n\n* To check the safety of ASP2138 and how well people can tolerate medical problems during the study.\n* To find a suitable dose of ASP2138 to be used later in the study.\n* These are done for ASP2138 given by itself and when given together with the standard cancer treatments.\n\nAdults 18 years or older with stomach cancer, GEJ cancer, or pancreatic cancer can take part. Their cancer is locally advanced unresectable or metastatic. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. There should also be the CLDN18.2 marker in a tumor sample. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers, have specific infections, have a condition such as hemophagocytic lymphohistiocytosis (HLH) which is when the body over-reacts to a \"trigger\" such as infection, or have a specific heart condition (\"New York Heart Association Class III or IV\").\n\nPhase 1: Lower to higher doses of ASP2138\n\n* ASP2138 is either given through a vein (intravenous infusion) or just under the skin (subcutaneous injection).\n* Different small groups are given lower to higher doses of ASAP2138.\n* ASP2138 is either given by itself, or given with 1 of 3 standard treatments:\n* Pembrolizumab and mFOLFOX6 (first treatment for gastric GEJ cancer)\n* Ramacirumab and paclitaxel (Second treatment for gastric or GEJ cancer)\n* ASP2138 with mFOLFIRINOX (first treatment for pancreatic cancer)\n\nPhase 1b: doses of ASP2138 worked out from Phase 1\n\n* ASP2138 is either given through a vein or just under the skin. This depends on the findings from Phase 1.\n* People with gastric cancer, GEJ cancer or pancreatic cancer are given doses of ASP2138, worked out from Phase 1.\n* This includes doses of ASP2138 given by itself and ASP2138 given with the standard cancer treatments.\n* The standard cancer treatments given depends on the type of cancer they have.\n\nEnd of treatment visit: This is 7 days after final dose of study treatment or if the study doctor decides to stop the person's treatment.\n\nPeople who have locally advanced unresectable pancreatic cancer will not receive ASP2138 by itself.",[267,268,78],[270,271,333,167,359],{"date":367,"type":54},{"date":389,"type":54},"2022-06-07",{"date":391,"type":20},"2028-05-31",{"name":60,"class":61},46,{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":21,"phases":403,"briefSummary":404,"conditions":405,"keywords":407,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":416},"100594835","phase-1-a-study-of-asp2138-given-before-surgery-then-chemotherapy-after-surgery-in-people-with-pancreatic-ductal-cancer-100594835","NCT07024615","A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer","A Phase 1b Study of Neoadjuvant ASP2138 Monotherapy and Investigator's Choice of Adjuvant Chemotherapy in Participants With Resectable Pancreatic Ductal Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression","Inclusion Criteria:\n\n* Participant has histologically confirmed localized pancreatic adenocarcinoma which is deemed upfront resectable based on institutional multi-disciplinary review. Participant with localized pancreatic adenocarcinoma cannot have received any prior therapy.\n* Participant has confirmation of positive claudin (CLDN)18.2 test result by local laboratory prior to first dose of study intervention (ASP2138 dosing may be allowed after discussion with the medical monitor, if results are pending or a biopsy for CLDN18.2 testing is not clinically appropriate). Site should contact the sponsor to assess potential eligibility based on a local test result.\n* Participant has an available pretreatment tumor sample, if clinically appropriate and meets requirements.\n* Participant is able to undergo surgery and treatment with adjuvant chemotherapy per institutional standard of care.\n* Participant with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function of class 2B or better using the New York Heart Association Functional Classification.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * WOCBP who has a negative serum pregnancy test at screening and agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy package insert \\[PI\\]\u002Fprescribing information, whichever is longer).\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (6 months) after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI\u002Fprescribing information, whichever is longer).\n* Female participant must not donate ova starting at first administration of neoadjuvant ASP2138, throughout the investigational period, and for 6 months after final ASP2138 administration (or follow the contraception requirements per the adjuvant chemotherapy PI\u002Fprescribing information, whichever is longer).\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 6 months after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI\u002Fprescribing information, whichever is longer).\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI\u002Fprescribing information, whichever is longer).\n* Male participant must not donate sperm during the treatment period and for 6 months after ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI\u002Fprescribing information, whichever is longer).\n* Participant has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 28 days prior to the first dose of study intervention per investigator assessment.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participant has a corrected QT interval by Fridericia (QTcF) ≤ 470 msec.\n* Participant must meet all of the criteria based on laboratory tests within 7 days prior to the first dose of study intervention. Participant has adequate organ and marrow function. If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 1 week after any blood transfusion.\n* Participant agrees not to participate in another interventional study while receiving study intervention in the present study.\n\nExclusion Criteria:\n\n* Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.\n* Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study intervention.\n* Participant has active autoimmune disease that has required systemic immunosuppressive treatment within the past 1 month prior to the start of study intervention.\n* Participant has uncontrolled serious psychiatric illness or social situations that would preclude study compliance.\n* Participant has another malignancy for which treatment is required.\n* Participant has a history or complication of interstitial lung disease.\n* Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent\u002Frecurrent vomiting.\n* Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency. NOTE: Applicable if participant is receiving fluoropyrimidine containing chemotherapy. Screening for DPD deficiency should be conducted per local requirements.\n* Participant has known, existing uncontrolled coagulopathy. Concomitant treatment with full dose warfarin (coumadin) is not allowed.\n\n  * Participant may receive low molecular weight heparin (LMWH) (such as enoxaparin and dalteparin) and direct oral anticoagulant (DOAC) for management of deep venous thrombosis (DVT).\n* Participant has a history of bleeding diathesis or recent major bleeding events (i.e. Grade ≥ 2 bleeding events in the month prior to treatment).\n* Participant has uncontrolled intercurrent illness or infection.\n* Participant is known to have human immunodeficiency virus (HIV) infection. However, participants with cluster of differentiation (CD) 4+ T cell counts ≥ 350 cells\u002FµL and no history of acquired immunodeficiency syndrome (AIDS) defining opportunistic infections within the past 6 months are eligible. NOTE: Screening for HIV infection should be conducted per local requirements.\n* Participant is known to have active hepatitis B (positive hepatitis B surface antigen \\[hBsAg\\]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements. NOTE: Screening for these infections should be conducted per local requirements.\n\n  * For participant who is negative for hBsAg, but hepatitis B core (HBc) Ab positive, an HBV DNA test will be performed and if positive the participant will be excluded.\n  * Participant with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results is eligible.\n  * Participant treated for HCV with undetectable viral load results is eligible.\n* Participant has a known history of UGT1A1 gene polymorphism resulting in complete loss of function of the UGT1A1 gene product (for participants receiving irinotecan containing chemotherapy).\n* Participant has any pre-existing severe gastric conditions such as active gastritis or ulcer that could be exacerbated by treatment.\n* Participant has received any prior chemotherapy, radiation therapy, immunotherapy, or biologic (\"targeted\") therapy or investigational therapy for treatment of the participant's pancreatic tumor.\n* Participant has received a live vaccine within 30 days of planned start of study therapy. NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed.\n* Participant has any condition including clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.\n* Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention.\n* Participant has had a major surgical procedure 28 days before start of study intervention and has not fully recovered.",{"count":402,"type":20},25,[73],"Some people with pancreatic ductal cancer (PDAC) have a protein called Claudin 18.2 (CLDN18.2) in their tumor. ASP2138 is thought to work by binding to CLDN18.2 and a protein on a type of immune cell called a T-cell. The T-cell \"tells\" the immune system to attack the tumor. This study is for people with resectable PDAC. Resectable means that the tumor can be removed by surgery.\n\nIn this study, adults with resectable PDAC will receive an ASP2138 injection just below the skin (subcutaneous) 2 weeks before surgery. After surgery, they will be given standard chemotherapy treatments chosen by their study doctor. These include mFOLFIRINOX, gemcitabine with nab-paclitaxel, or gemcitabine with capecitabine.\n\nPeople will receive chemotherapy treatment for up to 6 months, or until their cancer gets worse, they cannot tolerate the chemotherapy, or they or their study doctor thinks they should stop chemotherapy. People will have a final clinic visit about a month after finishing chemotherapy for health checks.",[406],"Pancreatic Ductal Adenocarcinoma",[270,271,167,359],"2026-05-27",{"date":410,"type":54},"2026-05-28",{"date":412,"type":54},"2025-10-16",{"date":414,"type":20},"2028-01-31",{"name":60,"class":61},3,{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":21,"phases":425,"briefSummary":427,"conditions":428,"keywords":430,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":438},"100582354","phase-4-a-safety-study-of-enfortumab-vedotin-in-indian-adults-with-urothelial-cancer-100582354","NCT06862219","A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer","A Multicenter, Phase 4, Open-label, Single-arm, Safety Study of Enfortumab Vedotin in Adult Indian Participants With Previously Treated Locally Advanced or Metastatic Urothelial Cancer","Inclusion Criteria:\n\n* Participant has histologically or cytologically confirmed urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter or urethra). Participants with urothelial carcinoma (transitional cell) with squamous differentiation or mixed cell types are eligible.\n* Participant must have experienced radiographic progression or relapse during or after a checkpoint inhibitor (CPI) (anti-PD-1 or anti-PD-L1) for locally advanced (LA) or metastatic disease. Participants who discontinued CPI treatment due to toxicity are eligible provided that they have evidence of disease progression following discontinuation. The CPI need not be the most recent therapy. Participants for whom the most recent therapy has been a non-CPI based regimen are eligible if they have progressed \u002F relapsed during or after their most recent therapy. LA disease must not be amenable to resection with curative intent.\n* Participant must have received a platinum-containing regimen (cisplatin or carboplatin) in the metastatic \u002F LA, neoadjuvant or adjuvant setting. If platinum was administered in the ajuvant\u002Fneoadjuvant setting, the participant must have progressed within 12 months of completion.\n* Participant must have measurable metastatic or LA disease at baseline according to RECIST version 1.1.\n* Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participant's baseline laboratory data meets protocol specified of criteria.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * WOCBP who has a negative urine or serum pregnancy test at screening or within 7 days prior to day 1 and agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final study intervention administration.\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for approximately 6 months after final study intervention administration.\n* Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 6 months after final study intervention administration.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 6 months after final study intervention administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after final study intervention administration.\n* Male participant must not donate sperm during the treatment period and for 6 months after final study intervention administration.\n* Participant agrees not to participate in another interventional study while receiving study intervention in the present study.\n\nExclusion Criteria:\n\n* Participant has preexisting sensory or motor neuropathy grade ≥ 2.\n* Participant has active central nervous system (CNS) metastases. Participant with treated CNS metastases is permitted on study if all the following are true:\n\n  * CNS metastases have been clinically stable for at least 6 weeks prior to screening\n  * If requiring steroid treatment for CNS metastases, the participant is on a stable dose ≤ 20 mg\u002Fday of prednisone or equivalent for at least 2 weeks\n  * Baseline scans show no evidence of new or enlarged brain metastasis\n  * Participant does not have leptomeningeal disease\n* Participant has ongoing clinically significant toxicity (grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).\n\n  * Participant with ≤ grade 2 immunotherapy-related hypothyroidism or panhypopituitarism may be enrolled when well-maintained \u002F controlled on a stable dose of hormone replacement therapy (HRT) (if indicated).\n  * Participant with ongoing ≥ grade 3 immunotherapy-related hypothyroidism or panhypopituitarism are excluded.\n  * Participant with ongoing immunotherapy-related colitis, uveitis, myocarditis or pneumonitis, or participant with other immunotherapy-related AEs requiring high doses of steroids (\\> 20 mg\u002Fday of prednisone or equivalent) are excluded.\n* Participant has history of another malignancy within 3 years before the first dose of study intervention or any evidence of residual disease from a previously diagnosed malignancy.\n\n  * Participant with non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance \u002F watchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed.\n* Participant with a positive hepatitis B surface antigen and\u002For anti-hepatitis B core antibody and a negative polymerase chain reaction assay at baseline should receive appropriate antiviral prophylaxis or regular surveillance monitoring as per local or institutional guidelines.\n* Participant has active hepatitis C infection or known human immunodeficiency virus infection. Participant who has been treated for hepatitis C infection is permitted if they have documented sustained virologic response of ≥ 12 weeks.\n* Participant has documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III to IV within 6 months prior to the first dose of study intervention administration.\n* Participant has known active keratitis or corneal ulcerations. Participant with superficial punctate keratitis is allowed if the disorder is being adequately treated.\n* Participant has other underlying medical condition that would impair the ability of the participant to receive or tolerate the planned treatment and follow-up.\n* Participant has history of uncontrolled diabetes mellitus within 3 months of the first dose of study intervention. Uncontrolled diabetes is defined as HbA1c ≥ 8 percent or HbA1c between 7 percent and \\\u003C 8 percent with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.\n* Participant has prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody drug conjugate (ADCs).\n* Participant is currently receiving systemic antimicrobial treatment for viral, bacterial, or fungal infection at the time of first dose of enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.\n* Participant has radiotherapy or major surgery within 4 weeks prior to first dose study intervention administration.\n* Participant has had chemotherapy, biologics, investigational agents, and\u002For antitumor treatment with immunotherapy that is not completed 2 weeks prior to first dose of study intervention administration.\n* Participant has any condition which makes the participant unsuitable for study participation.\n* Participant has a known or suspected hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate, and polysorbate 20); OR participant has known hypersensitivity to biopharmaceuticals produced in CHO cells.",{"count":318,"type":20},[426],"PHASE4","This study is for Indian adults in India who have cancer in the bladder lining (urothelial cancer). Their cancer is advanced or has spread to other parts of the body. Enfortumab vedotin is a treatment for this type of cancer.\n\nThe main aim of the study is to confirm the safety of enfortumab vedotin in Indian adults with urothelial cancer.\n\nDuring the study, people will receive enfortumab vedotin. The study treatment will be given to people slowly through a tube into a vein. This is called an infusion. People will receive 3 separate infusions of enfortumab vedotin in each 28-day (4 weeks) treatment cycle.\n\nPeople visit their study clinic for health-checks several times during and after they receive enfortumab vedotin.",[429],"Metastatic Urothelial Carcinoma",[111,109,431,110],"Urothelial cancer",{"date":410,"type":54},{"date":434,"type":54},"2025-06-21",{"date":436,"type":20},"2027-12-31",{"name":60,"class":61},13,{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":11,"sex":446,"minAge":17,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":21,"phases":449,"briefSummary":450,"conditions":451,"keywords":455,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":466},"100593339","phase-2-a-phase-2-study-to-evaluate-the-effects-of-asp5541-in-participants-with-prostate-cancer-100593339","NCT07005154","A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer","A Phase 2, Open-label, Multi-cohort Study to Assess the Efficacy and Safety of ASP5541 in Participants With Advanced Prostate Cancer","Inclusion Criteria:\n\n* Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.\n* Participant has ECOG performance status of 0 or 1, or ECOG performance status of 2 if due to bone pain.\n* Participant must have an estimated life expectancy of ≥ 12 months with mHSPC or ≥ 6 months with mCRPC.\n* Participant is able to understand and comply with all study requirements and procedures.\n* Participant has been diagnosed with mCRPC or mHSPC documented by metastatic lesions on a bone scan, computed tomography (CT), magnetic resonance imaging (MRI) or prostate-specific membrane antigen positron emission tomography (PSMA-PET).\n* Participant is receiving ongoing ADT with a gonadotropin-releasing hormone (GnRH) analogue or has a history of bilateral orchiectomy (i.e., surgical or medical castration). Participant with mHSPC must have started castration therapy (medical or surgical) at least 14 days prior to Cycle 1 Day 1 (C1D1).\n\nNote: Participant who has not had a bilateral orchiectomy must have a plan to maintain effective GnRH analogue therapy for the duration of the study.\n\n* If the participant has mCRPC, participant has evidence of disease progression defined as 1 or more of the following criteria at study entry:\n\n  * Evidence of radiographic progression of disease prior to first dose and following the most recent prostate cancer treatment, defined as progressive disease on CT\u002FMRI per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or on a bone scan per PCWG3.\n  * PSA progression defined as an increase in PSA of at least 25% and ≥ 1 ng\u002FmL above the nadir, confirmed by a second value 1 week later, and with at least 1 of the measurements within 90 days prior to screening. PSA nadir is defined as the lowest PSA during or after the most recent treatment.\n* If the participant has mCRPC, participant has a serum testosterone level \\\u003C 1.73 nmol\u002FL (\\\u003C 50 ng\u002FdL) at the Screening visit.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 7 months after final ASP5541 administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 7 months after final ASP5541 administration.\n* Male participant must not donate sperm during the treatment period and for 7 months after final ASP5541 administration.\n* Participant agrees not to participate in another interventional study while receiving ASP5541 in the present study.\n* Participant should have normal serum potassium (within the local laboratory normal range) at screening without supplementation.\n\nExclusion Criteria:\n\n* Participant has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.\n* Participant has known active central nervous system (CNS) metastases. Note: Participant with CNS metastases who has been treated with surgery and\u002For radiation therapy, who is off pharmacologic doses of glucocorticoids and who is neurologically stable is eligible.\n* Participant has a known additional malignancy beyond prostate cancer that requires active treatment with the exception of any of the following:\n\n  * Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type\n  * Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥ 2 years\n  * Any other cancer from which the participant has been disease-free for ≥5 years\n* Participant has clinically significant cardiac disease, defined as any of the following:\n\n  * Clinically significant cardiac arrhythmias including bradyarrhythmia which are poorly controlled. Rate-controlled atrial fibrillation is permitted.\n  * Congenital long QT syndrome.\n  * QT interval corrected by Fridericia's formula (QTcF) ≥450 msec at Screening. If the QT interval corrected for heart rate intervals (QTc) is prolonged in a participant with a pacemaker or bundle branch block, the participant may be enrolled in the study if confirmed by the medical monitor.\n  * History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II or left ventricular ejection fraction measurement of \\\u003C 50% at baseline.\n  * Cohorts 1 and 3: Participant must not have unstable angina (symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months.\n  * Cohort 2: Participants must not have symptomatic heart failure, unstable or new-onset angina or myocardial infarction within the past 12 months.\n  * Cohorts 1 and 3: Uncontrolled hypertension, defined as systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg that has been confirmed by 2 successive measurements despite optimal medical management.\n  * Cohort 2: Uncontrolled hypertension, defined as systolic BP \\> 140 mmHg or diastolic BP \\> 90 mmHg that has been confirmed by 2 successive measurements despite optimal medical management. Participants may be receiving a maximum of 2 antihypertensives that were initiated at least 3 months prior to Cycle 1 Day 1.\n  * Cohort 1 and 3: Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 3 months before start of study medication (except for adequately treated catheter related venous thrombosis occurring \\> 1 month before Cycle 1 Day 1).\n  * Cohort 2: Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within the last 12 months.\n* Participant has any unresolved National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.0) Grade \\> 2 toxicity at the Screening visit. Note: Participant receiving ongoing hormone replacement therapy for endocrine immune-related AEs without clinical symptoms will not be excluded.\n* Participant has had major surgery (e.g., requiring general anesthesia) within 30 days before screening, or has not fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study.\n* Participant has\u002Fhad febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day 1.\n* Participant received a blood transfusion within 1 month of the first dose of study intervention.\n* Participant has a history of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome).\n* Participant has hemoglobin A1c (HbA1c) \\> 10% (if diabetes mellitus was previously diagnosed) or HbA1c \\> 8% (if diabetes mellitus was previously undiagnosed). (Excluded participant may be rescreened after referral and evidence of improved control of their condition.)\n* Participant has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus IgM positive, but testing for hepatitis A in screening is not required), hepatitis B (hepatitis B virus surface antigen positive, confirmed by hepatitis B virus DNA), or hepatitis C (hepatitis C virus antibody positive, confirmed by hepatitis C virus RNA).\n* Participant has moderate or severe hepatic impairment (Child-Pugh Class B or C).\n* Participant has a known history of human immunodeficiency virus (HIV) infection (HIV antibody positive).\n* Participant has a body mass index \\> 40 kg\u002Fm2.\n* Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria within 2 years before screening.\n* Participant received treatment with glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to C1D1. The use of topical, intraocular, inhalational, intranasal or intra-articular glucocorticoids is permitted.\n* Participant received treatment with herbal medications with known anti-cancer properties or known effects on prostate physiology within 4 weeks prior to Cycle 1 Day 1 (e.g., saw palmetto, St. John's wort, turmeric\u002Fcurcumin). Participants must agree not to use herbal products during study participation.\n* Participant is receiving current treatment with systemic ketoconazole, abiraterone acetate (AA) or any other cytochrome P450 17A1 (CYP17) inhibitor. Participant who has received systemic ketoconazole, AA or any other CYP17 inhibitor must have discontinued these agents ≥ 4 weeks prior to the first dose of study intervention.\n* Participant received prior systemic treatment with a strong inducer or inhibitor of cytochrome p450 3A4 (CYP3A4) within 4 weeks of first dose of study intervention. Concomitant use of strong inducers or inhibitors of CYP3A4 are not permitted on study.\n* Participant requires use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg. Note: Participant who switches from a high dose to a dose of 30 μg\u002Fday or less prior to first dose of study drug is eligible for study entry.\n* Participant is required to use any prohibited medication on the List of Excluded Concomitant Medications.\n* For mCRPC participants only: Participant has been treated with any of the following for prostate cancer, during the indicated time frame prior to enrollment:\n\n  * Hormonal therapy (e.g., androgen receptor blockers \\[AR\\] antagonists, second-generation androgen receptor pathway inhibitors \\[including enzalutamide, apalutamide, darolutamide, rezvilutamide and AA\\], 5-alpha reductase inhibitors, estrogens, cyproterone acetate) within 4 weeks of C1D1. Note: Participant has been treated with bicalutamide within 6 weeks prior to enrollment is not permitted. Participant has been treated with all other GnRH analogues or antagonists is permitted.\n  * Chemotherapy within 2 weeks or 5 half-lives of C1D1 (whichever is longer)\n  * Biologic therapy within 4 weeks of C1D1\n  * Immunotherapy within 4 weeks of C1D1\n  * Radiation therapy (includes radioligands) within 4 weeks of C1D1\n* For mHSPC participants only: Participant has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):\n\n  * Up to 4 months of ADT with GnRH agonists or antagonists or orchiectomy (within 3 months prior to C1D1) with or without concurrent antiandrogens.\n  * Participant may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to C1D1.\n  * Up to 6 cycles of docetaxel therapy, with the last dose of docetaxel ≤ 2 months prior to C1D1. A participant who has received docetaxel should have maintained a response to docetaxel of stable disease or better, by imaging and PSA, prior to C1D1.\n  * Up to 6 months of ADT with GnRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to C1D1 if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to C1D1.\n* Participant has received any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to C1D1.\n* Participant has received ASP5541 previously.\n* Participant has absolute neutrophil count \\\u003C 1500\u002FμL, platelet count \\\u003C 100000\u002FμL or hemoglobin \\\u003C 9 g\u002FdL (6.2 mmol\u002FL) or international normalized ratio (INR) ≥ 1.5 (unless participant is taking oral anticoagulants in which case INR ≤ 2.0 is permitted) at Screening. Note: Participant may not have received any growth factors within 7 days or blood transfusions within 28 days prior to the hematology values obtained at Screening.\n* Participant has serum total bilirubin \\> 1.5 x upper limit of normal (ULN) (or \\> 3 x ULN for participants with documented Gilbert's disease), or serum alanine aminotransferase or aspartate aminotransferase \\> 2.5 x ULN at Screening.\n* Participant does not have adequate renal function defined as a calculated creatinine clearance \\\u003C 30 mL\u002Fmin as determined by a validated algorithm for calculating creatinine clearance.\n* Participant has serum albumin \\\u003C 3.0 g\u002FdL (30 g\u002FL) at Screening.\n* Participant has a known or suspected hypersensitivity to ASP5541, prednisone, or any components of the formulations used.\n* Participant has a gastrointestinal disorder affecting absorption.","MALE",{"count":448,"type":20},218,[74],"Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of the main male sex hormone, testosterone in the body. Androgen receptor pathway inhibitors (ARPIs) are another type of hormone therapy. They either slow down how much testosterone is made or block testosterone from reaching the prostate cancer cells. Abiraterone acetate (AA) is an ARPI that is used to treat advanced prostate cancer. This type of treatment is usually given as a tablet with a steroid called prednisone\u002Fprednisolone to manage any medical problems from the hormone therapy.\n\nASP5541 is a different form of abiraterone acetate. It is given as an injection into the muscle. In this study, ASP5541 will be given to men with advanced prostate cancer, both with and without prednisone\u002Fprednisolone. This study will check the safety of ASP5541 and compare how well ASP5541 works in men with advanced prostate cancer compared to abiraterone acetate.\n\nThe main aims of the study are:\n\n* To check how well ASP5541 with prednisone\u002Fprednisolone works compared to AA with prednisone\u002Fprednisolone in men with advanced prostate cancer who haven't previously been treated with an ARPI.\n* To check the safety of ASP5541 given by itself in men with advanced prostate cancer that haven't previously been treated with an ARPI.\n* To check how well ASP5541 given by itself works compared to AA with prednisone\u002Fprednisolone in men with advanced prostate cancer that haven't previously been treated with an ARPI.\n* To check the safety of ASP5541 with prednisone\u002Fprednisolone in Japanese men with advanced prostate cancer.\n\nAdult men with a certain type of advanced prostate cancer can take part. Their cancer has spread to other parts of the body (metastatic). The different types are:\n\n* Metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer that needs testosterone to grow.\n* Metastatic castration-resistant prostate cancer (mCRPC). Prostate cancer that continues to grow even when testosterone levels are low.\n\nIn this study there will be 3 treatment groups:\n\n* In Group 1, men with mCRPC who haven't previously been treated with an androgen receptor pathway inhibitor will either be given ASP5541 and prednisone\u002Fprednisolone or be given abiraterone acetate and prednisone\u002Fprednisolone.\n* In Group 2, men with mHSPC who haven't previously been treated with an androgen receptor pathway inhibitor will either be given ASP5541 by itself or be given abiraterone acetate with prednisone\u002Fprednisolone.\n* In Group 3, Japanese men with mCRPC or mHSPC who may or may not have previously been treated with an androgen receptor pathway inhibitor will be given ASP5541 with prednisone\u002Fprednisolone.\n\nASP5541 will be given as an injection into a muscle every 12 weeks. Men with mCRPC will take prednisone\u002Fprednisolone twice daily and men with mHSPC will take prednisone\u002Fprednisolone once daily. Abiraterone acetate will be given as tablets to be taken once daily. All groups will also receive the standard of care treatment, such as androgen deprivation therapy.\n\nThe men in the study will visit their clinic regularly during and after treatment for health checks, including checking for any medical problems. Some men (Group 2) will check their blood pressure weekly at home. On some visits they will also have scans to check for any changes in their cancer. The number of visits and type of safety checks done at each visit will depend on the health of each person and when they completed their treatment.",[452,453,454],"Prostate Cancer","Metastatic Castration-Resistant Prostate Cancer","Metastatic Hormone Sensitive Prostate Cancer",[456,457],"ASP5541","PRL-02","2026-04-30",{"date":460,"type":54},"2026-05-01",{"date":462,"type":54},"2025-06-19",{"date":464,"type":20},"2032-05-31",{"name":60,"class":61},33,{"id":468,"slug":469,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":446,"minAge":17,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":21,"phases":476,"briefSummary":477,"conditions":478,"keywords":479,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":492,"locationsCount":493},"100282706","phase-2-a-study-for-subjects-with-prostate-cancer-who-previously-participated-in-an-enzalutamide-clinical-study-100282706","NCT02960022","A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study","A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study","Inclusion Criteria:\n\n* Subject must currently be receiving enzalutamide or assigned to receive enzalutamide (if on treatment suspension) for prostate cancer in a study sponsored by Astellas or Medivation and, based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.\n* Subject is able to continue on the treatment regimen that they were receiving or were assigned to receive in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dose change in Androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.\n* Subject is able to swallow enzalutamide capsules and comply with study requirements.\n* Subject and female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective and 1 must be a barrier method throughout the study and for 3 months after final enzalutamide administration.\n* Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.\n* Subject agrees not to participate in another interventional study while on treatment.\n\nCanada Specific:\n\n* Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization for the United States sites) must be obtained from the subject prior to any study-related procedures.\n* Subject must currently be receiving enzalutamide for breast cancer in a study sponsored by Astellas or Medivation\u002FPfizer and based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.\n* Subject is able to continue on the treatment regimen that they were receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.\n* Subject is able to swallow enzalutamide capsules and comply with study requirements.\n* Subject is either:\n* Of nonchildbearing potential:\n* postmenopausal (defined as no spontaneous menses for at least 12 months prior to Day 1 with follicle stimulating hormone (FSH) \\> 40 IU\u002FL at Day 1 for women \\\u003C 55 years of age),\n* documented surgically sterile or status post hysterectomy (at least 1 month prior to Day 1),\n* Or, if of childbearing potential,\n* must have a negative urine pregnancy test at Day 1 before the first dose of study drug is administered,\n* must use 2 acceptable methods of birth control starting at Day 1 and through 6 months after the final study drug administration,\n* must not donate ova starting at first administration of study intervention and throughout 6 months after final study intervention administration.\n\nThe 2 acceptable methods of birth control are as follows or per local guidelines where these require additional description of contraceptive methods:\n\n* A barrier method (e.g., condom by a male partner) is required; AND\n* One of the following is required:\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS);\n* Additional barrier method including occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository;\n* Vasectomy or other surgical castration at least 6 months before Day 1.\n* The subject must not be breastfeeding at Day 1 or during the study period, and for 6 months after the final study drug administration.\n* Subject agrees not to participate in another interventional study while on treatment.\n\nExclusion Criteria:\n\n* Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from.\n* Subject requires treatment with or plans to use either of the following:\n\n  * New systemic therapy for subjects cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment.\n  * Investigational therapy other than enzalutamide.\n* Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.\n* Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.\n\nCanada Specific:\n\nSubject will be excluded from participation if any of the following apply:\n\n* Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which they are enrolling from.\n* Subject requires treatment with or plans to use any of the following:\n* New systemic therapy for their cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment.\n* Investigational therapy other than enzalutamide.\n* Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.\n* Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data in the opinion of the investigator.",{"count":475,"type":20},900,[74],"The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.",[452],[480,481,482,483,484,485],"prostate cancer","prednisone","MDV3100","enzalutamide","Xtandi","abiraterone acetate","2026-04-07",{"date":488,"type":54},"2026-04-13",{"date":490,"type":54},"2016-12-22",{"date":92,"type":20},{"name":60,"class":61},241,{"id":495,"slug":496,"hasResults":11,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":21,"phases":503,"briefSummary":504,"conditions":505,"keywords":507,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":519,"locationsCount":520},"100494544","phase-1-a-study-of-asp1002-in-adults-for-treatment-of-solid-tumors-100494544","NCT05719558","A Study of ASP1002 in Adults for Treatment of Solid Tumors","A Phase 1 Study of ASP1002 in Participants With Metastatic or Locally Advanced Solid Tumors","Inclusion Criteria:\n\n* Participant has locally-advanced (unresectable or metastatic solid tumor which is confirmed by available pathology records or current biopsy.\n\n  1. For dose escalation, the participant must P the following malignancies (for all tumor types, any component of neuroendocrine histology is exclusionary):\n\n     I. NSCLC - adenocarcinoma, squamous cell carcinoma and adenosquamous are included; large cell carcinoma and sarcomatoid carcinoma are excluded.\n\n     Note: NSCLC Not Otherwise Specified will require documented discussion with the medical monitor prior to study entry II. UC II. CRC IV. Prostate adenocarcinoma V. Epithelial ovarian cancer (including fallopian tube cancer) VI. TNBC\n     * TNBC defined as unequivocal TNBC histology (ER 1 negative\u002Fprogesterone receptor-negative\u002FHER2-negative). This is defined by \\\u003C 1% expression of ER and progesterone receptor by IHC and that are, for HER2, either 0 to 1+ by IHC, or IHC 2+ and FISH negative (not amplified) as per current ASCO\u002FCAP guidelines \\[Hammond et al, 2010\\].\n  2. For dose expansion, the participant must have one of the following malignancies (for all tumor types, any component of neuroendocrine histology is not eligible):\n\n     I. NSCLC - adenocarcinoma, squamous cell carcinoma and adenosquamous are included; large cell carcinoma and sarcomatoid carcinoma are excluded. Note: NSCLC Not Otherwise Specified will require documented discussion with the medical monitor prior to study entry.\n\n     II. UC III. CRC IV. Tumor type for which a confirmed response was observed during dose escalation.\n* Female participant is not pregnant, confirmed by pregnancy test (and medical evaluation by interview \\[UNIQUE to Japan\\]), and at least 1 of the following conditions apply:\n\n  1. Not a woman of childbearing potential (WOCBP)\n  2. WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 90 days after final study intervention administration.\n* Participant has progressed, is intolerant, has refused, or there are no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).\n* Participant has accessible archival tumor tissue (\\\u003C 6 months old) from either the primary tumor or a metastatic site, for which source and availability have been confirmed prior to study intervention; participants without available tissue should undergo a mandatory biopsy. If the participant is unable to undergo a biopsy due to safety concerns, enrollment into the study is at the discretion of the medical monitor. Participant should undergo a tumor biopsy during the treatment period as indicated in the schedule of assessments. Note: Tumor tissue collection (at screening\u002Fbaseline and on-treatment) is optional for participants enrolled initially in dose levels 1 to 3 in dose escalation; however, protocol de-escalation and expansion of dose levels similar to dose levels 1 to 3 may require collection and processing of screening\u002Fbaseline and on-treatment tumor samples.\n* Participant has at least 1 measurable lesion per RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) Status of 0 or 1.\n* Participants who have received radiotherapy must have completed this therapy (including stereotactic radiosurgery) at least 2 weeks prior to study intervention administration.\n* Participant has predicted life expectancy \\>\u002F= 12 weeks.\n* Participant has adequate organ function prior to start of study intervention. If a participant has received a recent blood transfusion, the laboratory tests must be obtained \\>\u002F=2 weeks after any blood transfusion.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * a. Not a woman of childbearing potential (WOCBP)\n  * b. WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 90 days after final study intervention administration.\n* Female participant must agree not to breastfeed starting at screening and throughout the study period and for 90 days after final study intervention administration.\n* Female participant must not donate ova starting at first administration of study intervention and throughout 90 days after final study intervention administration.\n* Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 90 days after final study intervention administration.\n* Male participant must not donate sperm during the treatment period and for 90 days after final study intervention administration.\n* Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 90 days after final study intervention administration.\n* Participant agrees not to participate in another interventional study while receiving study intervention in the present study.\n\nExclusion Criteria:\n\n* Participant weighs \\\u003C 40 kg.\n* Participant has ongoing toxicity \\>\u002F= grade 2 per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 considered clinically significant and attributable to prior antineoplastic therapies.\n* Participant has symptomatic CNS metastases or evidence of uncontrolled CNS disease even if asymptomatic (e.g. progression on scans). Participants with previously treated CNS metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study intervention and are not requiring immunosuppressive doses of systemic steroids (equivalent to \\> 10 mg per day of prednisone) for longer than 2 weeks.\n* Participant has an active autoimmune disease. Participant with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, or skin disorders (e.g., vitiligo, psoriasis or alopecia) not requiring systemic treatment are allowed.\n* Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study intervention or currently has an uncontrolled illness including, but not limited to, symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, complete left bundle branch block, obligate use of a cardiac pacemaker, long QT syndrome or right bundle branch block with left anterior hemiblock (bifascicular block).\n* Participant has a corrected corrected QT interval (QTcF) interval (single electrocardiogram (ECG)) \\> 470 ms within 7 days prior to the first study intervention administration on day 1.\n* Participant has left ventricular ejection fraction (LVEF) \\\u003C 45% noted in screening echocardiogram (ECHO). Any clinically significant findings from this ECHO should be discussed with the medical monitor.\n* Participant is known to have human immunodeficiency virus (HIV) infection. However, participants with HIV infection with CD4+ T cell counts \\>\u002F=350 cells\u002FμL and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 6 months are eligible. Note: No HIV testing is required at screening unless mandated per local requirements.\n* Participant has any of the following per screening serology test:\n\n  * a. Hepatitis A virus antibodies immunoglobulin (IgM)\n  * b. Positive hepatitis B surface antigen (HBsAg) or detectable hepatitis B Deoxyribonucleic Acid (DNA). Participant with negative HBsAg, positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antibody (anti-HBs) are eligible if hepatitis B DNA is undetectable\n  * c. hepatitis C virus (HCV) antibodies unless HCV Ribonucleic acid (RNA) is undetectable\n  * d HCV antibodies, and antigens (UNIQUE to Japan), unless HCV RNA is undetectable.\n* Participant has a history of drug-induced pneumonitis, interstitial lung disease (ILD), currently has pneumonitis, or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids.\n\n  * UNIQUE to Japan: Participant has a history of interstitial pneumonia.\n* Participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, any form of substance abuse or psychiatric illness\u002Fsocial situations that would limit compliance with study visits or requirements or a condition that could invalidate communication with the investigator.\n* Participant has received a prior allogeneic bone marrow or solid organ transplant.\n* Participant has had a major surgical procedure and has not completely recovered within 28 days prior to the start of study intervention.\n* Participant with recent positive antigen test for Coronavirus Disease 2019 (COVID-19) within 10 days prior to study intervention administration. Note: Participants who are asymptomatic after 10 days from the first positive antigen test may be enrolled.\n* Participant has received any investigational therapy or antineoplastic therapy or other immunotherapy within 21 days or 5 half-lives, whichever is shorter, prior to the first dose of study intervention. Note: Participants with prostate adenocarcinoma who do not have a bilateral orchiectomy should continue androgen deprivation therapy (ADT) during the study. A participant with epidermal growth factor receptor (EGFR), receptor tyrosine kinase (encoded by the gene ROS1), or anaplastic lymphoma kinase (ALK) mutation-positive NSCLC is allowed to remain on EGFR tyrosine receptor inhibitor, neurotrophic tyrosine receptor kinase inhibitor or ALK inhibitor therapy until 4 days prior to the start of study intervention administration.\n* Participant requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to ASP1002 administration. Participants using a physiologic replacement dose of corticosteroids equivalent to 10 mg per day of prednisone or less are allowed, as is receiving a single dose of systemic corticosteroids, or receiving systemic corticosteroids as premedication for radiologic imaging contrast is eligible.\n* Participant was discontinued from prior immunomodulatory therapy due to a grade \\>\u002F=3 toxicity that was mechanistically related (e.g., immune-related) to the agent and deemed life-threatening.\n* Participant is expected to require another form of antineoplastic therapy while on study intervention.\n* Participant has another malignancy requiring active therapy; (other than those indicated in Inclusion Criterion No. 1).\n* Participants who have received prior anti-CD137 therapy.\n* Participant has received a live vaccine against infectious diseases within 28 days prior to initiation of study intervention.\n* Participant has any condition makes the participant unsuitable for study participation.\n* Participant has a known or suspected hypersensitivity to ASP1002 or any components of the formulation used.",{"count":502,"type":20},210,[73],"The main aims of this study are:\n\n* To check the safety of ASP1002 in people with certain solid tumors.\n* To check if the people can tolerate ASP1002.\n* To find a suitable dose of ASP1002. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP1002. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP1002 to use in Part 2 of the study.\n\nIn Part 2, other different small groups of people will receive doses of ASP1002 that worked the best in Part 1.\n\nPeople in this study will be adults with metastatic or locally advanced solid tumors with high levels of a protein called claudin 4. The people's cancer will have either spread to other parts of the body (metastatic) or spread to tissue close by (locally advanced).\n\nThey will have been previously treated with available standard therapies or refused to receive those treatments.\n\nIn both parts of the study, ASP1002 (the study treatment) will be given to people slowly through a tube into a vein. This is called an infusion. This will happen every week, every other week, or every 3 weeks, in treatment cycles. Treatment cycles may be 21 days or 28 days long. People in this study will continue treatment for up to 2 years until: they have medical problems that prevent them from continuing treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; they do not come back for treatment.\n\nDuring the study, people will visit the clinic several times for a health check. This includes standard safety checks and reporting any medical problems. Every few weeks, the study doctors will check if each person's cancer has stayed the same or got worse. This will be done by scans (CT or MRI scans). Tumor samples will be taken during the study and people will have the option of giving a tumor sample after treatment has finished.\n\nPeople will visit the clinic within 7 days after stopping treatment for a health check. Then, they may visit the clinic at 1 month and 3 months after stopping treatment for further health checks. People will have follow-up health checks for up to 1 year after their last dose of ASP1002.",[506],"Advanced Solid Tumors",[508,509,510,511,512,333],"Solid Tumor;","Malignancy;","Metastasis;","cancer;","ASP1002;","2026-03-17",{"date":515,"type":54},"2026-03-18",{"date":517,"type":54},"2023-03-13",{"date":391,"type":20},{"name":60,"class":61},15,{"id":522,"slug":523,"hasResults":11,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":528,"sex":16,"minAge":17,"maxAge":529,"enrollmentInfo":530,"targetDuration":4,"studyType":21,"phases":532,"briefSummary":533,"conditions":534,"keywords":536,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":550},"100623314","phase-1-a-study-to-learn-how-fluconazole-carbamazepine-and-itraconazole-affect-how-the-body-processes-asp3082-in-healthy-adults-100623314","NCT07395024","A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults","A Phase 1 Crossover Design Study to Assess the Effect of CYP3A Moderate and Strong Inhibitors (Fluconazole and Itraconazole) and Strong Inducer (Carbamazepine) on the Single-dose Pharmacokinetics of ASP3082 in Healthy Adults","Inclusion Criteria:\n\n* Participant is healthy and has no clinically significant medical condition based on the physical examination, electrocardiograms (ECGs) and protocol-defined clinical laboratory tests at screening or on day -1.\n* Female participant is not pregnant and is not a woman of childbearing potential (WOCBP)\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (approximately 28 days after final study intervention administration).\n* Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 3 months after final study intervention administration.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 3 months after final study intervention administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 3 months after final study intervention administration.\n* Male participant must not donate sperm during the treatment period and for 3 months after final study intervention administration.\n* Participant agrees not to participate in another interventional study while participating in the present study.\n* Participant has a Body Mass Index (BMI) range of 18.0 to 32.0 kg\u002Fm\\^2, inclusive, and weighs at least 50 kg at screening.\n\nExclusion Criteria:\n\n* Participant is positive for Human Leukocyte Antigen (HLA) -B15:02 or HLA-A31:01, for Group 2 only.\n* Participant has been pregnant within 6 months prior to screening.\n* Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and\u002For other major disease.\n* Participant has a history of malignancy within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that is considered cured with minimal risk of recurrence).\n* Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 5 half-lives (approximately 28 days) after the last dose of study drug administration or end-of-study visit (ESV), whichever is longer.\n* Participant has\u002Fhad febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day -1.\n* Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) DSM-5 criteria within 2 years before screening.\n* Participant has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease or a family history of long QT syndrome.\n* Participant has used any prescribed or nonprescribed drugs (including vitamins, and natural and herbal remedies, e.g., St. John's wort) in the 28 days prior to day -1, except for occasional use of acetaminophen (up to 2 g\u002Fday), topical dermatological products (including corticosteroid products) and hormone replacement therapy (HRT).\n* Participant has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 28 days prior to day -1.\n* Participant has received a coronavirus disease 2019 (COVID-19) vaccine within the 14 days prior to day -1 or will have a COVID-19 vaccine dose before the ESV.\n* Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.\n* Participant has any liver test result alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin (TBL )) ≥ 1.5 ×upper limit of normal (ULN ) on day -1.\n* Participant has a creatinine level outside normal limits on day -1.\n* Participant has any of the following conditions on day -1: a mean pulse \\\u003C 45 or \\> 90 bpm, mean systolic blood pressure (SBP ) \\> 140 mmHg, or mean diastolic blood pressure (DBP) \\> 90 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes; pulse measured automatically). If the mean blood pressure exceeds the limits above, 1 additional triplicate measurement may be taken.\n* Participant has a mean corrected QT interval using Fridericia's formula (QTcF ) of \\> 450 msec on day -1.\n* Participant tests positive for alcohol at screening or on day -1.\n* Participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) at screening or on day -1.\n* Participant tests positive for cannabinoids on day -1.\n* Participant has a positive serology test for hepatitis A virus (HAV) antibodies immunoglobulin M (IgM), hepatitis B (HBc) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or antibodies to human immunodeficiency virus (HIV ) type 1 and\u002For type 2 at screening.\n* Participant has a positive rapid COVID-19 antigen test on day -1.\n* Participant has any condition that makes the participant unsuitable for study participation.\n* Participant has a known or suspected hypersensitivity to ASP3082 or any components of the formulation used.\n* Participant has a history of smoking \\> 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to day -1 or the participant tests positive for cotinine at screening or day -1.\n* Participant has a history of consuming \\> 10 units of alcoholic beverages per week within 3 months prior to screening (Note: 1 unit = 12 ounces of beer, 5 ounces of wine, 1.5 ounces of spirits\u002Fhard liquor).\n* Participant has used any drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine and\u002For opiates) within 3 months prior to day -1.\n* Participant has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and\u002For received a transfusion of any blood or blood products within 60 days prior to day -1.\n* Participant has had previous exposure to ASP3082.\n* Participant is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.",true,"65 Years",{"count":531,"type":20},54,[73],"Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Some people with solid tumors have a faulty KRAS gene. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation.\n\nASP3082 is thought to replace some of the abnormal proteins made from the faulty KRAS gene. If other medicines are given at the same time as ASP3082, they may affect how the body processes ASP3082.\n\nIn this study, fluconazole, itraconazole and carbamazepine are given with ASP3082 in healthy adults. The main aims are to check if fluconazole, itraconazole and carbamazepine affect how the body processes ASP3082. These medicines may affect how the body processes ASP3082 when they are taken at the same time.\n\nThis study will have 3 groups of adults. One group will be given fluconazole and ASP3082, the second group will be given carbamazepine and ASP3082, and the third group will be given itraconazole and ASP3082. ASP3082 will be given to people slowly through a tube into the vein (infusion). Fluconazole and carbamazepine will be given as a tablet and itraconazole will be given as a liquid by mouth. People will be given study treatments for about 1 month. They will then return to the clinic about 1 week after they finish study treatment for a final safety check.",[535],"Healthy Volunteer",[191,333,537,538,539,540,541],"Setidegrasib","Healthy Volunteers","Fluconazole","Itraconazole","Carbamazepine","2026-03-03",{"date":544,"type":54},"2026-03-05",{"date":546,"type":54},"2026-02-03",{"date":548,"type":20},"2026-07-31",{"name":60,"class":61},1,{"id":552,"slug":553,"hasResults":11,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":11,"sex":446,"minAge":17,"maxAge":558,"enrollmentInfo":559,"targetDuration":4,"studyType":21,"phases":561,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":550},"100619026","phase-1-a-study-to-evaluate-the-safety-and-drug-levels-of-asp5541-in-chinese-participants-with-prostate-cancer-100619026","NCT07339267","A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer","A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety of ASP5541 in Chinese Participants With Advanced Prostate Cancer","Inclusion Criteria:\n\n* Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.\n* Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or ECOG performance status of 2 if due to bone pain.\n* Participant must have an estimated life expectancy of ≥ 12 months with metastatic hormone-sensitive prostate cancer (mHSPC) or ≥ 6 months with metastatic castration-resistant prostate cancer (mCRPC).\n* Participant is able to understand and comply with all study requirements and procedures.\n* Participant has been diagnosed with mCRPC or mHSPC documented by metastatic lesions on a bone scan, computed tomography (CT), magnetic resonance imaging (MRI) or prostate-specific membrane antigen positron emission tomography (PSMA-PET).\n* Participant is receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or has a history of bilateral orchiectomy (i.e., surgical or medical castration). Participant with mHSPC must have started castration therapy (medical or surgical) at least 14 days prior to Cycle 1 Day 1 (C1D1).\n\nNote: Participant who has not had a bilateral orchiectomy must have a plan to maintain effective GnRH analogue therapy for the duration of the study.\n\n* If the participant has mCRPC, participant has evidence of disease progression defined as 1 or more of the following criteria at study entry:\n\n  * Evidence of radiographic progression of disease prior to first dose and following the most recent prostate cancer treatment, defined as progressive disease on CT\u002FMRI per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or on a bone scan per PCWG3.\n  * PSA progression defined as an increase in PSA of at least 25% and ≥ 1 ng\u002FmL above the nadir, confirmed by a second value 1 week later, and with at least 1 of the measurements within 90 days prior to screening. PSA nadir is defined as the lowest PSA during or after the most recent treatment.\n* If the participant has mCRPC, participant has a serum testosterone level \\\u003C 1.73 nmol\u002FL (\\\u003C 50 ng\u002FdL) at the Screening visit.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 7 months after final ASP5541 administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 7 months after final ASP5541 administration.\n* Male participant must not donate sperm during the treatment period and for 7 months after final ASP5541 administration.\n* Participant has adequate ventrogluteal muscle mass for an intramuscular injection.\n* Participant agrees not to participate in another interventional study while receiving ASP5541 in the present study.\n\nExclusion Criteria:\n\n* Participant has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.\n* Participant has known active central nervous system (CNS) metastases. Note: Participant with CNS metastases who has been treated with surgery and\u002For radiation therapy, who is off pharmacologic doses of glucocorticoids and who is neurologically stable is eligible.\n* Participant has a known additional malignancy beyond prostate cancer that requires active treatment with the exception of any of the following:\n\n  * Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type\n  * Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥ 2 years\n  * Any other cancer from which the participant has been disease-free for ≥5 years\n* Participant has clinically significant cardiac disease, defined as any of the following:\n\n  * Clinically significant cardiac arrhythmias including bradyarrhythmia which are poorly controlled. Rate-controlled atrial fibrillation is permitted.\n  * Congenital long QT syndrome.\n  * QT interval corrected by Fridericia's formula (QTcF) ≥450 msec at Screening. If the QT interval corrected for heart rate intervals (QTc) is prolonged in a participant with a pacemaker or bundle branch block, the participant may be enrolled in the study if confirmed by the medical monitor.\n  * History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II or left ventricular ejection fraction measurement of \\\u003C 50% at baseline. Participant must not have unstable angina (symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months.\n  * Uncontrolled hypertension, defined as systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg that has been confirmed by 2 successive measurements despite optimal medical management.\n  * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 3 months before start of study medication (except for adequately treated catheter related venous thrombosis occurring \\> 1 month before the start of study medication).\n* Participant has any unresolved National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.0) Grade \\> 2 toxicity at the Screening visit. Note: Participant receiving ongoing hormone replacement therapy for endocrine immune-related AEs without clinical symptoms will not be excluded.\n* Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study.\n* Participant has\u002Fhad febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day 1.\n* Participant received a blood transfusion within 1 month of the first dose of study intervention.\n* Participant has a history of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome).\n* Participant has hemoglobin A1c (HbA1c) \\> 10% (if diabetes mellitus was previously diagnosed) or HbA1c \\> 8% (if diabetes mellitus was previously undiagnosed). (Excluded participant may be rescreened after referral and evidence of improved control of their condition.)\n* Participant has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus IgM positive, but testing for hepatitis A in screening is not required), hepatitis B (hepatitis B virus surface antigen positive, confirmed by hepatitis B virus DNA), or hepatitis C (hepatitis C virus antibody positive, confirmed by hepatitis C virus RNA).\n* Participant has moderate or severe hepatic impairment (Child-Pugh Class B or C).\n* Participant has a known history of human immunodeficiency virus (HIV) infection (HIV antibody positive).\n* Participant has a body mass index \\> 40 kg\u002Fm2.\n* Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria within 2 years before screening.\n* Participant received treatment with glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to C1D1. The use of topical, intraocular, inhalational, intranasal or intra-articular glucocorticoids is permitted.\n* Participant received treatment with Chinese traditional medications with known antitumor activity or herbal products within 4 weeks prior to C1D1 (e.g., saw palmetto). Participant must agree not to use such Chinese traditional medications or herbal products during study participation.\n* Participant is receiving current treatment with systemic ketoconazole, abiraterone acetate (AA) or any other cytochrome P450 17A1 (CYP17) inhibitor. Participant who has received systemic ketoconazole, AA or any other CYP17 inhibitor must have discontinued these agents ≥ 4 weeks prior to the first dose of study intervention.\n* Participant received prior systemic treatment with a strong inducer or inhibitor of cytochrome p450 3A4 (CYP3A4) within 4 weeks of first dose of study intervention. Concomitant use of strong inducers or inhibitors of CYP3A4 are not permitted on study.\n* Participant requires use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg. Note: Participant who switches from a high dose to a dose of 30 μg\u002Fday or less prior to first dose of study drug is eligible for study entry.\n* Participant is required to use any prohibited medication on the List of Excluded Concomitant Medications.\n* For mCRPC participants only: Participant has been treated with any of the following for prostate cancer, during the indicated time frame prior to enrollment:\n\n  * Hormonal therapy (e.g., androgen receptor blockers \\[AR\\] antagonists, second-generation androgen receptor pathway inhibitors \\[including enzalutamide, apalutamide, darolutamide, rezvilutamide and AA\\], 5-alpha reductase inhibitors, estrogens, cyproterone acetate) within 4 weeks of C1D1. Note: Participant has been treated with bicalutamide within 6 weeks prior to enrollment is not permitted. Participant has been treated with all other GnRH analogues or antagonists is permitted.\n  * Chemotherapy within 2 weeks or 5 half-lives of C1D1 (whichever is longer)\n  * Biologic therapy within 4 weeks of C1D1\n  * Immunotherapy within 4 weeks of C1D1\n  * Radiation therapy (includes radioligands) within 4 weeks of C1D1\n* For mHSPC participants only: Participant has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):\n\n  * Up to 4 months of ADT with GnRH agonists or antagonists or orchiectomy (within 3 months prior to C1D1) with or without concurrent antiandrogens.\n  * Participant may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to C1D1.\n  * Up to 6 cycles of docetaxel therapy, with the last dose of docetaxel ≤ 2 months prior to C1D1. A participant who has received docetaxel should have maintained a response to docetaxel of stable disease or better, by imaging and PSA, prior to C1D1.\n  * Up to 6 months of ADT with GnRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to C1D1 if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to C1D1.\n* Participant has received any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to C1D1.\n* Participant has received ASP5541 previously.\n* Participant has absolute neutrophil count \\\u003C 1500\u002FμL, platelet count \\\u003C 100000\u002FμL or hemoglobin \\\u003C 9 g\u002FdL (6.2 mmol\u002FL) or international normalized ratio (INR) ≥ 1.5 (unless participant is taking oral anticoagulants in which case INR ≤ 2.0 is permitted) at Screening. Note: Participant may not have received any growth factors within 7 days or blood transfusions within 28 days prior to the hematology values obtained at Screening.\n* Participant has serum total bilirubin \\> 1.5 x upper limit of normal (ULN) (except participants with documented Gilbert's disease), or serum alanine aminotransferase or aspartate aminotransferase \\> 2.5 x ULN at Screening.\n* Participant does not have adequate renal function defined as a calculated creatinine clearance \\\u003C 30 mL\u002Fmin as determined by a validated algorithm for calculating creatinine clearance.\n* Participant has serum albumin \\\u003C 3.0 g\u002FdL (30 g\u002FL) at Screening.\n* Participant has a known or suspected hypersensitivity to ASP5541, prednisone, or any components of the formulations used.\n* Participant has a gastrointestinal disorder affecting absorption.","85 Years",{"count":560,"type":20},12,[73],"In this study, ASP5541 will be given to Chinese men with prostate cancer. It will be given together with prednisone and androgen deprivation therapy (ADT). Prednisone is a steroid, and ADT is already given to the men as their standard of care for prostate cancer.\n\nThe main aims of the study are to check the safety of ASP5541, when given with prednisone and ADT, and to check how ASP5541 moves through the bodies of Chinese men.\n\nThe men will receive ASP5541 as an injection into a muscle (intramuscular injection) at the side of the hip. They will all receive the same dose of ASP5541. The men will be given prednisone and ADT according to their label.\n\nThe men will continue to receive ASP5541 with prednisone and ADT until their cancer gets worse or the doctor decides the men should stop study treatment.",[452,453,454],[456,457,333],"2026-02-16",{"date":567,"type":54},"2026-02-18",{"date":569,"type":54},"2026-01-20",{"date":571,"type":20},"2028-12-31",{"name":60,"class":61},{"id":574,"slug":575,"hasResults":11,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":11,"sex":446,"minAge":17,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":21,"phases":582,"briefSummary":583,"conditions":584,"keywords":587,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":402},"100418469","phase-1-a-safety-and-dose-finding-study-of-prl-02-depot-in-men-with-advanced-prostate-cancer-100418469","NCT04729114","A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer","Phase 1, Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer","Inclusion Criteria:\n\n* Histological evidence of adenocarcinoma of the prostate\n* Phase 1a Dose Escalation Groups A and B: participants must have one of the following documented conditions:\n\n  * mCSPC (must have documentation by positive bone scan \\[for bone disease\\] or metastatic lesions on computed tomography \\[CT\\] or magnetic resonance imaging \\[MRI\\] scan \\[for soft tissue\\])\n  * nmCSPC with biochemical relapse of prostate cancer\n  * mCSPC with oligometastatic prostate cancer (e.g., positron emission tomography positive)\n  * mCRPC (must have documentation by positive bone scan \\[for bone disease\\] or metastatic lesions on CT or MRI scan \\[for soft tissue\\])\n  * NOTE: For participants in the Dose Escalation Cohorts (including backfill) at each of the dose levels up to approximately 10 participants with ARPI-naïve mCRPC who have not received prior treatment with an ARPI (e.g., abiraterone acetate, enzalutamide, apalutamide, darolutamide) will be enrolled.\n* Phase 1a Dose Escalation Groups A and B: participants with mCRPC must have evidence of disease progression defined as one or more of the following:\n\n  * Evidence of radiographic progression of disease following the most recent prostate cancer treatment, defined as progressive disease on CT\u002FMRI per RECIST v1.1 or on a bone scan per PCWG3.\n  * PSA progression defined as the following:\n* PSA nadir is defined as the lowest PSA during or after the most recent treatment. PSA progression is defined as an increased PSA of at least 25% and ≥1 ng\u002FmL above the nadir confirmed by at least 2 measurements with a minimum of 1 week apart, and with at least 1 of the measurements within 90 days prior to screening.\n* Participants with nmCSPC and biochemical recurrence, who had a radical prostatectomy (with or without radiotherapy) as the primary treatment for prostate cancer, must have a screening PSA ≥1 ng\u002FmL. Participants with nmCSPC and biochemical recurrence who had radiotherapy only, as primary treatment for prostate cancer, must have a screening PSA ≥2 ng\u002FmL above the nadir.\n* Phase 1b Expansion Groups D and E: participants must have mCRPC Participants in Group D must have received prior treatment with abiraterone acetate, but must not have received treatment with other ARPIs (enzalutamide, apalutamide or darolutamide). Participants in Group E must have received prior treatment with only 1 of the following ARPIs: enzalutamide, apalutamide or darolutamide. Participants in both Groups D and E must have documented evidence of progression with one or more of the following:\n\n  * Evidence of radiographic progression of disease following the most recent prostate cancer treatment, defined as progressive disease on CT\u002FMRI per RECIST v1.1 or on a bone scan per PCWG3. Disease spread that is limited to the regional pelvic lymph nodes does not qualify as radiographic progression.\n  * PSA progression defined as the following:\n  * PSA nadir is defined as the lowest PSA during or after the most recent treatment. PSA progression is defined as an increased PSA of at least 25% and ≥1 ng\u002FmL above the nadir confirmed by at least 2 measurements with a minimum of 1 week apart, and with at least 1 of the measurements within 90 days prior to screening.\n* Participants with mCRPC must have undergone bilateral orchiectomy or received concurrent GnRH agonist or antagonist therapy for at least 6 weeks prior to the first dose of study drug.\n* Participants with mCSPC or nmCSPC with biochemical recurrence should have received \\\u003C6 months of ADT with a GnRH agonist or antagonist or have a history of bilateral orchiectomy (i.e., surgical or medical castration) within 6 months prior to Day 1. Castration therapy (i.e., medical or surgical) must have been started at least 14 days prior to Cycle 1 Day 1 and participants should have no radiographic evidence of disease progression or rising PSA levels after starting ADT and prior to Cycle 1 Day 1.\n* A serum testosterone level \\\u003C50 ng\u002FdL at screening (for mCRPC participants only)\n* Adequate muscle mass for an i.m. injection\n* An ECOG PS of 0 or 1\n* Adequate bone marrow reserve defined as:\n\n  * Absolute neutrophil count (ANC) ≥1500\u002FµL\n  * Platelet count ≥100,000\u002FµL\n  * Hemoglobin ≥9 gm\u002FdL\n* Adequate renal function defined as a serum creatinine ≤1.5 × upper limit of normal (ULN) for the reference laboratory or a calculated creatinine clearance ≥50 mL\u002Fmin as determined by a validated algorithm for calculating creatinine clearance\n* Adequate hepatic function, defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN and total bilirubin ≤1.5 × ULN. Exception for elevated bilirubin secondary to Gilbert's disease. Confirmation of Gilbert's diagnosis requires: elevated unconjugated (indirect) bilirubin values; normal complete blood count in previous 12 months, blood smear, and reticulocyte count; normal aminotransferases and alkaline phosphatase in previous 12 months.\n* Serum albumin ≥3 gm\u002FdL and serum potassium ≥3.5 mEq\u002FL\n* Participants who are non-sterile and who are heterosexually active with a female partner of childbearing potential must be willing to use a highly effective means of contraception, such as a male condom plus spermicide, from the time of screening, throughout the total duration of the drug treatment, and until 12 weeks after the final dose of PRL-02 or enzalutamide (Group H).\n* Participant is able to comply with study requirements throughout the study.\n\nThe Following Inclusion Criteria Apply to Dose Escalation Group H Only\n\n* Participants must have one of the following documented conditions:\n\n  * mCSPC (must have documentation of a positive PMSA-PET or positive bone scan \\[for bone disease\\] or metastatic lesions on CT or MRI scan \\[for soft tissue\\])\n  * mCRPC (must have documentation of a positive PMSA-PET or positive bone scan \\[for bone disease\\] or metastatic lesions on CT or MRI scan \\[for soft tissue\\])\n  * NOTE: For participants in the Dose Escalation Cohorts (including backfill) at each of the dose levels, the Sponsor may elect to enroll up to 10 participants with ARPI-naïve mCRPC who have not received prior treatment with an ARPI (e.g., abiraterone acetate, enzalutamide, apalutamide, darolutamide).\n* Participants with mCRPC must have evidence of disease progression defined as one or more of the following:\n\n  * Evidence of radiographic progression of disease following the most recent prostate cancer treatment, defined as progressive disease on CT\u002FMRI per RECIST v1.1 or on a bone scan per PCWG3.\n  * PSA progression defined as the following:\n* PSA nadir is defined as the lowest PSA during or after the most recent treatment. PSA progression is defined as an increased PSA of at least 25% and ≥1 ng\u002FmL above the nadir confirmed by at least 2 measurements with a minimum of 1 week apart, and with at least 1 of the measurements within 90 days prior to screening.\n* Participant is able to swallow enzalutamide capsules whole.\n\nExclusion Criteria:\n\n* Known active central nervous system (CNS) metastases. Note: Participants with CNS metastases that have been treated with surgery and\u002For radiation therapy, who are off pharmacologic doses of glucocorticoids, and who are neurologically stable are eligible.\n* Impending bone fracture due to bone metastases\n* Has a known additional malignancy beyond prostate cancer that required active treatment with the exception of any of the following:\n\n  * Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type\n  * Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥2 years\n  * Any other cancer from which the participant has been disease-free for ≥5 years\n* Clinically significant cardiac disease, defined as any of the following:\n\n  * Clinically significant cardiac arrhythmias including bradyarrhythmia which are poorly controlled.\n  * Congenital long QT syndrome\n  * QT interval corrected by Fridericia's formula (QTcF) ≥450 msec at screening (based on average of triplicate ECGs at baseline). If the QT interval corrected for heart rate intervals (QTc) is prolonged in a participant with a pacemaker or bundle branch block, the participant may be enrolled in the study if confirmed by the Medical Monitor.\n  * History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II or left ventricular ejection fraction measurement of \\\u003C50% at baseline. Participants must not have unstable angina (symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months \\[NYHA Classification 2014\\].\n  * Uncontrolled hypertension, defined as systolic blood pressure (BP) \\>160 mmHg or diastolic BP \\>100 mmHg which has been confirmed by 2 successive measurements despite optimal medical management.\n  * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 3 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring \\>1 month before the start of study medication).\n* Received an investigational drug within 4 weeks or 5 half-lives (whichever is shorter) of the first dose of study drug.\n* Received chemotherapy within 2 weeks or 5 half-lives (whichever is shorter) of the first dose of study drug.\n\n  * Additional criteria: ARPI-naïve mCRPC participants enrolled in the Dose Escalation Cohorts (including backfill) must not have received prior chemotherapy in the mCRPC setting (prior receipt of chemotherapy in the mCSPC setting is allowed, if received at least 2 weeks or 5 half-lives prior to the first dose of study drug).\n* Any unresolved NCI CTCAE criteria v5.0 Grade \\>2 toxicity from previous anticancer therapy at the Screening visit. Note: Participants receiving ongoing hormone replacement therapy for endocrine immune-related AEs without clinical symptoms will not be excluded.\n* Has not recovered from recent major surgery or trauma\n* Received a blood transfusion within 2 weeks of the first dose of study drug\n* History of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome)\n* Prior treatment with abiraterone acetate, orteronel. Exception: participants in Phase 1b Expansion Group D will have received prior abiraterone acetate, and participants in Group H may have received prior treatment with abiraterone acetate.\n* Current treatment with systemic ketoconazole or any other CYP17 inhibitor. Participants who have received systemic ketoconazole or any other CYP17 inhibitor must have discontinued these agents ≥4 weeks prior to the first dose of study drug.\n* Prior systemic treatment with an azole drug (e.g., fluconazole, itraconazole) within 4 weeks of first dose of study drug.\n* Prior treatment with estrogens within 12 weeks of the first dose of study drug\n* Need for systemic glucocorticoids greater than replacement doses; the use of topical, intraocular, inhalational, intranasal, or intra-articular glucocorticoids is permitted.\n* Prior use of any herbal products that could decrease PSA levels (e.g., saw palmetto) within 4 weeks of the first dose of study drug. Participants must agree not to use such herbal products during study participation.\n* Use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg \\[NIH-ODS 2022\\]. Note: Participants who switch from a high dose to a dose of 30 µg\u002Fday or less prior to first dose of study drug are eligible for study entry.\n* Required concomitant use of strong inducers of CYP3A4, except for enzalutamide given as study drug in Group H\n* Known hypersensitivity to PRL-02, abiraterone, abiraterone decanoate, prednisone, or dexamethasone or any of their excipients or components.\n* Has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus immunoglobulin M \\[IgM\\] positive), hepatitis B (hepatitis B virus surface antigen \\[HBsAg\\] positive, confirmed by polymerase chain reaction \\[PCR\\]), or hepatitis C (hepatitis C virus \\[HCV\\] antibody positive, confirmed by HCV ribonucleic acid)\n* Hemoglobin A1c (HbA1c) \\>10% in participants previously diagnosed with diabetes mellitus. HbA1c \\>8% in participants whose diabetes mellitus is previously undiagnosed. (Excluded participants may be rescreened after referral and evidence of improved control of their condition).\n* Uncontrolled infection with human immunodeficiency virus (HIV)+. Exception: participants with well-controlled HIV (e.g., CD4 \\>350\u002Fmm3 and undetectable viral load) are eligible.\n* Body mass index \\>40 kg\u002Fm2\n\nThe Following Exclusion Criteria Apply to Dose Escalation Group H Only\n\n* Clinically significant cardiac disease, defined as any of the following:\n\n  * NYHA class III or IV congestive heart failure or a history of NYHA class III or IV congestive heart failure, unless a screening echocardiogram or multigated acquisition scan performed within 3 months before the randomization date demonstrates a left ventricular ejection fraction of ≥45%\n  * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place\n  * Hypotension as indicated by systolic BP \\\u003C86 mm Hg at screening\n  * Bradycardia as indicated by a heart rate of ≤45 beats per minute on the screening ECG\n* Participant has a history of seizure or any condition that may predispose to seizure.\n* Use or required use of any prohibited medication.\n* Participant has a gastrointestinal disorder affecting absorption.\n* Participant has shown hypersensitivity reaction to the active pharmaceutical ingredient or any of the study capsule components, including Labrasol®, butylated hydroxyanisole, and butylated hydroxytoluene.",{"count":581,"type":20},174,[73],"Medicines that reduce the amount of testosterone in the body are commonly used to treat prostate cancer. PRL-02 depot is a potential treatment for men with advanced prostate cancer. It is given by an injection into the muscle. Men with advanced prostate cancer can take part in this study. Their cancer has come back after previous cancer treatment, or the previous cancer treatment they had didn't work.\n\nThe main aims of the study are:\n\n* to check the safety of PRL-02 depot given with and without another medicine called enzalutamide.\n* to check if the men can tolerate PRL-02 depot given with or without enzalutamide.\n* to find a suitable dose of PRL-02 depot.\n\nThis study will be in 2 parts.\n\nIn the first part, different small groups of men will receive lower to higher doses of PRL-02 depot together with other medicines.\n\nIn the second part of the study, men who have previously taken a hormone therapy called abiraterone acetate or have previously taken 1 specific hormone therapy as part of their prostate cancer treatment can take part.\n\nMen in both parts of the study will receive injections of PRL-02 depot into a muscle once every 12 weeks. They will also take dexamethasone or prednisone, or enzalutamide once a day. The other medicines they take depend on which group and which part of the study they are in.\n\nDuring the study, the men will visit the clinic several times for health checks and scans.\n\nAfter the final visit, men whose cancer has not become worse will continue to have health checks and scans every few months.",[452,585,586],"Metastatic Castration Resistant Prostate Cancer","Metastatic Castration-sensitive Prostate Cancer",[588,589,590,591,592,480,593,594,595,596,485,597,598,456],"Testosterone","Testosterone suppression","metastatic castrate sensitive prostate cancer","metastatic castrate resistant prostate cancer","metastatic disease","mCSPC","mCRPC","abiraterone","abiraterone decanoate","Phase 1","Propella",{"date":600,"type":54},"2026-02-04",{"date":602,"type":54},"2021-06-14",{"date":604,"type":20},"2029-05-31",{"name":60,"class":61},{"id":607,"slug":608,"hasResults":11,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":613,"phases":4,"briefSummary":614,"conditions":615,"keywords":616,"overallStatus":622,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":626,"locationsCount":627},"100519786","early-access-program-for-zolbetuximab-100519786","NCT06048081","Early Access Program for Zolbetuximab","A Global, Multicenter, Open-label, Early Access Program for Zolbetuximab (IMAB362) Plus mFOLFOX6 or CAPOX in Patients With Claudin18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Patient has histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.\n* Patient has confirmed locally advanced, unresectable or metastatic gastric or GEJ adenocarcinoma.\n* Patient whose tumor expresses claudin18.2 (CLDN18.2) in ≥ 75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining as determined by local or central immunohistochemistry (IHC) testing.\n* Patient has a Human epidermal growth factor receptor 2 (HER2-negative) tumor by local testing on a gastric or GEJ tumor specimen.\n* Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Patient must meet all of the following criteria based on the locally analyzed laboratory tests collected.\n\n  * Hemoglobin (Hgb) ≥ 9 g\u002FdL. Patients requiring transfusions are eligible if they have post-transfusion Hgb ≥ 9 g\u002FdL.\n  * Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL\n  * Platelets ≥ 100 × 109\u002FL\n  * Albumin ≥ 2.5 g\u002FdL\n  * Total bilirubin (TBL) ≤ 1.5 × ULN without liver metastases (or \\\u003C 3.0 × ULN if liver metastases are present)\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) without liver metastases (or ≤ 5 × ULN if liver metastases are present)\n  * Estimated creatinine clearance ≥ 30 mL\u002Fmin\n  * Prothrombin time\u002Finternational normalized ratio (PT\u002FINR) and partial thromboplastin time ≤ 1.5 × ULN (except for patients receiving anticoagulation therapy)\n* Female patient is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of child bearing potential (WOCBP)\n  * WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final administration of oxaliplatin and 6 months after final administration of other interventions.\n* Female patient must agree not to breastfeed starting at screening and throughout the EAP period and for 6 months after final intervention administration.\n* Female patient must not donate ova starting at first administration of treatment and throughout the EAP period and for 9 months after the final administration of oxaliplatin and 6 months after final administration of other interventions.\n* Male patient with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 6 months after final treatment administration.\n* Male patient must not donate sperm during the treatment period and for 6 months after final treatment administration.\n* Male patient with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the EAP period and for 6 months after final treatment administration.\n\nExclusion Criteria:\n\n* Patient has previously received treatment in a clinical trial of zolbetuximab, or a clinical trial that included zolbetuximab as 1 of the treatment options, even if the patient was not given zolbetuximab.\n* Patient is a candidate for an ongoing clinical trial of zolbetuximab.\n* Patient has received any investigational therapy within 28 days or 5 half-lives prior to screening.\n* Patient has a known or suspected hypersensitivity to zolbetuximab, other monoclonal antibodies or any components of the formulation used.\n* Patient has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, patient may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as it was completed at least 6 months prior to participation.\n* Patient has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to program registration and has not recovered from any related toxicity.\n* Patient receiving treatment with herbal medications that have known antitumor activity.\n* Patient has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to registration. Patients using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg\u002Fday of hydrocortisone or up to 10 mg\u002Fday of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.\n* Patient has a prior severe allergic reaction, known (immediate or delayed) or suspected hypersensitivity, intolerance or contraindication to zolbetuximab, mFOLFOX6, CAPOX, other monoclonal antibodies or any components of the formulations used.\n* Patient has known dihydropyrimidine dehydrogenase (DPD) deficiency. (NOTE: Screening for DPD deficiency should be conducted per local requirements.)\n* Patient has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent\u002Frecurrent vomiting.\n* Patient has significant gastric bleeding and\u002For untreated gastric ulcers that would exclude the patient from participation.\n* Patient has any other condition, which makes the patient unsuitable to receive or tolerate zolbetuximab.","EXPANDED_ACCESS","This program is to provide zolbetuximab to people with stomach cancer or gastroesophageal junction (the junction between stomach and esophagus) cancer who have not yet been treated with chemotherapy, immunotherapy, or zolbetuximab and who have tested positive for claudin18.2 (a protein found in some cancer cells). People will work with their doctor to see if they are capable of being treated with zolbetuximab while they receive other standard medicines to treat their cancer. The program will allow people early access to zolbetuximab before the drug is fully approved.\n\nZolbetuximab will be given through a vein. This is called an infusion. The infusion will happen during a person's treatment with other cancer medicines. Zolbetuximab will be given every 3 weeks. People will continue treatment until: they have medical problems (unwanted side effects) from the treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; or they do not come back for treatment.\n\nPeople will visit the clinic on certain days during their treatment. During these visits, the program doctors will check for any medical problems (unwanted side effects) from zolbetuximab, other cancer treatment, or both. At some visits, other checks will include a medical examination, laboratory tests and vital signs. Vital signs include temperature, pulse, and blood pressure. Also, blood samples will be taken.\n\nPeople will visit the clinic within 7 days after stopping treatment. The program doctors will check for any medical problems (unwanted side effects) from zolbetuximab or their cancer treatment. Other checks will include a medical examination, laboratory tests, and vital signs. Then, people will have a follow-up visit about 30 days after stopping treatment. If people are having no health problems, the follow-up visit can happen over the telephone.",[137,138,139,135],[617,618,619,620,621,141,87],"Zolbetuximab","IMAB362","Modified oxaliplatin, folinic acid (leucovorin) and fluorouracim (FOLFOX6)","Capecitabine and oxaliplatin (CAPOX)","Early Access Program (EAP)","AVAILABLE","2025-09-09",{"date":625,"type":54},"2025-09-10",{"name":60,"class":61},140,""]