[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroesophageal-junction-gej-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroesophageal-junction-gej-adenocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,48,76,108,133,170,195],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053859","phase-2-perioperative-hlx10-serplulimab-with-s-1oxaliplatin-sox-in-locally-advanced-and-pd-l1-positive-gastric-or-esophagogastric-junction-adenocarcinoma-a-randomized-phase-2-investigator-initiated-trial-100053859",false,"NCT07699939","Perioperative HLX10 (Serplulimab) With S-1+Oxaliplatin (SOX) in Locally Advanced and PD-L1-Positive Gastric or Esophagogastric Junction Adenocarcinoma: A Randomized Phase 2 Investigator-Initiated Trial","PLATANUS","Inclusion Criteria:\n\n1. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma at the study site. (For gastroesophageal junction adenocarcinoma, only patients classified as Siewert type II or type III who do not require surgery involving simultaneous thoracoabdominal incision are eligible.)\n2. Tumor tissue determined to be PD-L1 positive (CPS \\>= 5) based on pre-screening evaluation by the central laboratory. 3) Diagnosis of cT3-4N1-3M0 disease according to the AJCC\u002FUICC-TNM 8th edition based on assessments performed within 28 days prior to randomization (the same day of the week 4 weeks before the randomization date is acceptable; the same applies hereafter), with no prior systemic treatment. Pre-randomization laparoscopy is not mandatory, but if performed, no non-curative factors (including liver metastasis, peritoneal metastasis, other distant metastases, or positive peritoneal cytology (CY1)) should be observed.\n\n4\\) Judged by the investigator as capable of undergoing R0 resection. 5) Age between 18 years and 80 years on the day of enrollment. 6) ECOG performance status (PS) of 0 or 1. 7) The most recent laboratory values obtained within 14 days prior to randomization meet all of the following (however, transfusion, recombinant human thrombopoietin, and administration of granulocyte colony-stimulating factor (G-CSF) within 14 days prior to blood collection are not permitted): (1) Neutrophil count \\>= 1500\u002Fmm\\^3 (2) Hemoglobin \\>= 9.0 g\u002FdL (3) Platelet count \\>= 10 x 10\\^4\u002Fmm\\^3 (4) Total bilirubin \\\u003C= 1.5 mg\u002FdL (5) AST \\\u003C= 100 U\u002FL (6) ALT \\\u003C= 100 U\u002FL (7) Serum albumin \\>= 3.0 g\u002FdL (8) Serum creatinine \\\u003C= 1.5 mg\u002FdL (9) APTT \\\u003C= 60 s (10) PT-INR \\\u003C= 1.5 8) Females of childbearing potential should test negative for pregnancy test (serum or urine) within 7 days prior to randomization (the same day of the week is acceptable).\n\n9\\) Male patients and females of childbearing potential agree to use contraception from the time of provision of informed consent through a specified period after the last administration of study treatment (until at least 120 days after the last dose of HLX10 and at least 180 days after the last dose of study drug other than HLX10 (S-1 or oxaliplatin)).\n\n10\\) Written informed consent for study participation has been obtained from the patient.\n\nExclusion Criteria:\n\n1. Presence of another active malignancy within 5 years prior to enrollment or concurrently. Patients with cured, localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, non-invasive prostate cancer, non-invasive cervical cancer, and non-invasive breast cancer are permitted.\n2. Patients scheduled to undergo organ transplantation or bone marrow transplantation.\n3. Myocardial infarction and\u002For uncontrolled arrhythmia (including QTc interval \\>= 450 ms in males or \\>= 470 ms in females) occurring within 6 months prior to randomization (QTc interval calculated using Fridericia's formula).\n4. Cardiac dysfunction classified as NYHA Class III-IV, or left ventricular ejection fraction (LVEF) \\\u003C 50 percent on echocardiography.\n5. Positive for any of the following: HIV antibody, HBs antigen, or HCV-RNA (HCV-RNA is measured only if HCV antibody is positive).\n6. HBs antigen negative, HBs antibody and\u002For HBc antibody positive, and quantitative HBV-DNA detectable (patients are not excluded if HBV-DNA is below the limit of detection).\n7. Active tuberculosis.\n8. Interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and\u002For severe pulmonary dysfunction that may interfere with evaluation and management of suspected drug-related pulmonary toxicity.\n9. Known active or suspected autoimmune disease, excluding patients whose disease is stable at randomization and who do not require systemic immunosuppressive therapy.\n10. Patients who received live vaccination within 28 days prior to randomization, except for inactivated virus vaccines used for seasonal influenza prophylaxis.\n11. Patients who require systemic corticosteroids (a therapeutic dose of \\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medications within 14 days prior to randomization or during the study period. However, in the absence of active autoimmune disease, patients are permitted to use steroids at a dose of \\\u003C= 10 mg\u002Fday prednisone or equivalent, or inhaled steroids, or adrenal hormone replacement therapy.\n12. Patients who have an active infection requiring systemic anti-infective treatment within 14 days prior to randomization, except for prophylactic antibiotic treatment (e.g., for prevention of urinary tract infection or chronic obstructive pulmonary disease).\n13. Prior treatment with other antibody or drug therapies for immune checkpoint blockade, such as PD-1, PD-L1, or CTLA-4 therapy.\n14. Patients currently receiving other clinical study treatment, or for whom the planned start of treatment in this study is \\\u003C 14 days from completion of the prior clinical study treatment.\n15. History of severe hypersensitivity to the monoclonal antibody or any component of the study drug.\n16. History of psychotropic drug abuse or drug dependence.\n17. Patients with a disease that may increase the risk associated with study participation and use of the study drug, or with other severe acute or chronic diseases that, in the investigator's judgment, render the patient unsuitable for participation in the study.","ALL","18 Years","80 Years",{"count":20,"type":21},136,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","To evaluate the clinical efficacy of perioperative treatment with S-1 + oxaliplatin (SOX)+ HLX10 compared with SOX as the control in patients with cT3-4N1-3M0 PD-L1-positive (CPS ≥ 5) locally advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, in a placebo-controlled, double-blind, randomized phase II investigator-initiated clinical study.",[27,28],"Gastric Adenocarcinoma","Gastroesophageal Junction (GEJ) Adenocarcinoma",[30,31,32,33,34],"SOX regimen","PD-1 inhibitor","Perioperative chemotherapy","serplulimab","Immuno-chemotherapy","NOT_YET_RECRUITING","2026-07-07",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":21},"2026-07-15",{"date":43,"type":21},"2029-06-30",{"name":45,"class":46},"National Cancer Center, Japan","OTHER_GOV",18,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"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":56,"type":21},570,[58],"PHASE3","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.",[27,28],[62,63,64,65],"Claudin (CLDN) 18.2","ASP2138","Advanced Unresectable or Metastatic Gastric Adenocarcinoma","Advanced Unresectable or Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma","2026-06-23",{"date":68,"type":39},"2026-06-29",{"date":70,"type":21},"2026-06-30",{"date":72,"type":21},"2031-02-28",{"name":74,"class":75},"Astellas Pharma Global Development, Inc.","INDUSTRY",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100614791","phase-1-first-in-human-study-of-plx-61639-in-locally-advanced-or-metastatic-solid-tumors-100614791","NCT07284186","First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors","A Phase 1, First-in-Human Study of the SMARCA2 Degrader, PLX-61639, in Patients With SMARCA4-Mutated Locally Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Participants with locally advanced or metastatic, relapsed\u002Frefractory, solid tumors harboring a SMARCA4 loss-of-function mutation that have progressed on, are intolerant of, or not otherwise candidates for available approved therapies\n* Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function\n* Measurable disease per RECIST 1.1\n* ECOG PS of 0 or 1\n\nKey Exclusion Criteria:\n\n* Germline SMARCA4 mutations\n* Known SMARCA2 mutation or loss of expression\n* Symptomatic CNS disease\n* Prior treatment with another SMARCA2-directed therapy\n* History of other malignancies\n* Clinically significant heart disease\n* Uncontrolled hypertension\n* Prolongation of QT interval",{"count":84,"type":21},155,[86],"PHASE1","A multicenter, single-arm, first-in-human study to investigate the safety, pharmacokinetics, and preliminary antitumor activity of PLX-61639 in participants with locally advanced or metastatic, relapsed\u002Frefractory, SMARCA4-deficient solid tumors who are intolerant of or have failed available, approved therapies.\n\nThe study will be conducted in 3 parts: dose escalation (Part 1), dose optimization (Part 2), and cohort expansion (Part 3). Each part of the study will consist of a Screening Phase lasting up to 28 days during which participants will be assessed for eligibility, a Treatment Phase beginning on Cycle 1 Day 1 and consisting of consecutive 28-day cycles, an End of Treatment Visit, and a Post-Treatment Follow-Up Phase.\n\nParticipants will receive their assigned dose of PLX-61639 administered orally, once daily until progression\u002Frelapse, intolerance, death, or withdrawal from study treatment by the Investigator or participant.",[89,27,90,28,91,92,93,94,95,96],"Esophageal Squamous Cell Carcinoma","Gastric Squamous Cell Carcinoma","Metastatic Solid Tumor","Non-Small Cell Lung Carcinoma","Esophageal Adenocarcinoma","SMARCA4 Mutation","Gastroesophageal Junction Squamous Cell Carcinoma","Advanced Solid Tumor","RECRUITING","2026-06-10",{"date":100,"type":39},"2026-06-12",{"date":102,"type":39},"2025-12-01",{"date":104,"type":21},"2030-09",{"name":106,"class":75},"Plexium, Inc.",10,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"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":116,"type":21},398,[86],"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.",[27,28,120],"Pancreatic Adenocarcinoma",[62,63,122,123,124],"Pharmacokinetics","Safety","Tolerability","2026-06-09",{"date":98,"type":39},{"date":128,"type":39},"2022-06-07",{"date":130,"type":21},"2028-05-31",{"name":74,"class":75},46,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":157,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":4},"100633678","phase-1-phase-12-study-of-bhb810-in-advanced-gastric-and-gej-adenocarcinoma-100633678","NCT07529808","Phase 1\u002F2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma","Phase 1\u002F2, Open-Label, Multicenter, Dose Escalation and Expansion Study of BHB810 in Participants With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.\n* Histologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on, was nonresponsive to, or for which no standard or available curative therapy exists.\n\n  * Participants in Phase 1 Backfill Cohorts \\& Phase 2 must be CDH17-positive by central testing.\n  * Other gastrointestinal (GI) tumor types may be enrolled in Backfill Cohorts and Phase 2.\n* At least 1 measurable target lesion at baseline per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)\n* Provision of FFPE archival tumor tissue. Additional fresh biopsies at screening are required in Phase 1 Backfill Cohorts and Phase 2.\n* Adequate organ and marrow function as defined in the protocol\n\nExclusion Criteria:\n\n* Prior cancer treatment as follows, relative to the first planned dose of trial intervention:\n\n  * Chemotherapy or targeted therapy withing 4 weeks or 5-halflives (whichever is shorter)\n  * Monoclonal antibody-based therapy (including ADCs) within 4 weeks\n  * Immune checkpoint inhibitors within 4 weeks\n  * Wide-field radiation therapy (\\>30% marrow-bearing bones) within 4 weeks or \\\u003C 2 weeks of focal palliative radiation to nontarget lesions\n* Prior treatment with a CDH17-directed therapy or an ADC with an auristatin (MMAE or MMAF)\n* Known hypersensitivity or allergic reaction to BHB810 or it's excipients\n* Left ventricular ejection fraction \\\u003C50% or history of congestive heart failure Class III\u002FIV\n* QTc interval \\> 470 msec, history of risk factors for Torsade de Pointes, or taking a medication known to prolong QT\u002FQTc\n* Pregnant or breastfeeding females, or if you or your partner are planning to become pregnant\n* Known or suspected brain metastases, leptomeningeal disease, or spinal cord compression. Participants with stable, treated brain metastases may be enrolled.\n* Current treatment with a strong CYP3A4 inhibitor or inducer, Pgp inhibitor, or CYP3A4 sensitive substrate within 2 weeks of first dose of trial intervention\n* Any condition that may compromise participant safety, compliance, or interfere with the evaluation of the study drug.",{"count":141,"type":21},164,[86,24],"This study is looking at how safe BHB810 is in adults with gastric and gastroesophageal adenocarcinoma (GEJ). The purpose of this study is also to look at: how well the study drug works, how the study drug moves into, through, and out of the body, and how your body reacts to the study drug. Participants will get an IV infusion of BHB810 every 2 weeks while on study treatment.",[145,27,146,147,148,28,149,150,151,152,153,154,155,156],"Gastric Cancer","Gastric (Stomach) Cancer","Gastroesophageal Adenocarcinoma","Gastroesophageal Cancer (GC)","Gastroesophageal Junction (GEJ) Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Adenocarcinoma","Gastrointestinal Cancers","Colorectal (Colon or Rectal) Cancer","Pancreatic Cancer","CDH17-positive Advanced Solid Tumors","Advanced Gastric Cancer",[158,159,160],"Antibody Drug Conjugate (ADC)","Monomethyl Auristatin E (MMAE)","CDH17 protein","2026-05-05",{"date":163,"type":39},"2026-05-08",{"date":165,"type":21},"2026-06",{"date":167,"type":21},"2028-12",{"name":169,"class":75},"BigHat Biosciences, Inc.",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":4},"100631994","phase-2-dynamic-ctdna-guided-adjuvant-therapy-in-cstage-iii-and-iva-gastric-or-gastroesophageal-junction-adenocarcinoma-100631994","NCT07507916","Dynamic ctDNA-Guided Adjuvant Therapy in cStage III and IVA Gastric or Gastroesophageal Junction Adenocarcinoma","Dynamic Circulating Tumor DNA-Guided Adjuvant Therapy in cStage III and IVA Gastric or Gastroesophageal Junction Adenocarcinoma：A Phase 2 Clinical Trial","Inclusion Criteria:\n\n1. Voluntarily participate in the study; fully understand the study and sign the written informed consent form (ICF); be willing and able to comply with all study procedures.\n2. Male or female patients aged ≥18 years and ≤75 years at the time of signing the ICF.\n3. Histologically confirmed, previously untreated gastric cancer or gastroesophageal junction (GEJ) cancer, with adenocarcinoma as the predominant histology. For GEJ cancer, only Siewert type III and Siewert type II tumors not requiring thoracotomy are eligible.\n4. Clinically confirmed stage III or stage IVA disease without distant metastasis, as assessed by the treating physician prior to enrollment.\n5. HER2-negative disease.\n6. Adequate cardiac function and deemed suitable for curative-intent surgical resection. Patients with ischemic heart disease, valvular disease, or other significant cardiac conditions should undergo preoperative evaluation by a cardiologist if clinically indicated.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to enrollment.\n8. Estimated life expectancy of at least 6 months.\n9. Negative hepatitis B surface antigen (HBsAg) and negative hepatitis B core antibody (HBcAb). If HBsAg-positive or HBcAb-positive, hepatitis B virus DNA (HBV-DNA) must be \\\u003C1000 copies\u002FmL, \\\u003C200 IU\u002FmL, or below the upper limit of normal (ULN) of the study center.\n10. Negative hepatitis C virus (HCV) antibody.\n11. Adequate organ function, defined as follows (without transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factors within 14 days prior to randomization):\n\n    Hematologic function\n    * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n    * Platelet count ≥ 100 × 10⁹\u002FL\n    * Hemoglobin ≥ 90 g\u002FL Hepatic function\n    * Total bilirubin ≤ 1.5 × ULN\n    * ALT ≤ 2.5 × ULN (≤ 5.0 × ULN in patients with liver metastases)\n    * AST ≤ 2.5 × ULN (≤ 5.0 × ULN in patients with liver metastases)\n    * Alkaline phosphatase ≤ 2.5 × ULN (≤ 5.0 × ULN in patients with liver and\u002For bone metastases)\n    * Albumin ≥ 25 g\u002FL Renal function\n    * Creatinine clearance ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula) Coagulation function\n    * Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN\n    * Prothrombin time (PT) ≤ 1.5 × ULN\n    * International normalized ratio (INR) ≤ 1.5 × ULN\n12. Female patients must meet one of the following:\n\n    * Postmenopausal (defined as ≥1 year without menstruation not due to other causes), or\n    * Surgically sterile (bilateral oophorectomy and\u002For hysterectomy), or\n    * Of childbearing potential and meeting all of the following:\n    * Negative serum pregnancy test within 7 days prior to enrollment;\n    * Agree to use highly effective contraception (annual failure rate \\\u003C1%) or remain abstinent from signing the ICF until at least 120 days after the last dose of study drug and 6 months after the last dose of chemotherapy;\n    * Not breastfeeding.\n13. Male patients must agree to abstain from heterosexual intercourse or use effective contraception during chemotherapy and for at least 6 months after the last dose of chemotherapy, and for at least 120 days after the last dose of study drug, if their partner is of childbearing potential or pregnant.\n\nExclusion Criteria:\n\n1. History of another active malignancy within the past 5 years or concurrent malignancy, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast.\n2. Presence of distant metastasis (M1) from gastric cancer.\n3. Prior or planned organ or bone marrow transplantation.\n4. History of myocardial infarction within 6 months prior to enrollment, or poorly controlled arrhythmia, including QTc prolongation (QTc ≥450 ms in males or ≥470 ms in females, calculated using Fridericia's formula).\n5. New York Heart Association (NYHA) class III-IV heart failure, or left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography.\n6. Known human immunodeficiency virus (HIV) infection.\n7. Active pulmonary tuberculosis.\n8. Current or prior interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe pulmonary dysfunction that may interfere with the assessment or management of suspected drug-related pulmonary toxicity.\n9. Known active or suspected autoimmune disease, except for patients with stable disease not requiring systemic immunosuppressive therapy at enrollment.\n10. Receipt of a live vaccine within 28 days prior to enrollment (seasonal influenza vaccines with inactivated virus are allowed).\n11. Requirement for systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressive therapy within 14 days prior to enrollment or during the study, except for:\n\n    * Topical or inhaled corticosteroids;\n    * Physiologic replacement therapy with prednisone ≤10 mg\u002Fday in the absence of active autoimmune disease.\n12. Active infection requiring systemic anti-infective therapy within 14 days prior to enrollment (prophylactic antibiotics, such as for urinary tract infection or chronic obstructive pulmonary disease, are allowed).\n13. Prior treatment with immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.\n14. Participation in another clinical study or receipt of investigational treatment within 14 days prior to initiation of this study.\n15. Known severe hypersensitivity to any monoclonal antibody or components of the study drugs.\n16. History of substance abuse or illicit drug use; patients who have stopped alcohol consumption may be enrolled.\n17. Any condition that, in the investigator's judgment, may increase the risk of study participation or interfere with study treatment, compliance, or evaluation.","75 Years",{"count":179,"type":21},32,[24],"This is a single-center, prospective, exploratory study evaluating the use of dynamic circulating tumor DNA (ctDNA) monitoring in the postoperative adjuvant treatment setting for patients with stage III or stage IVA gastric or gastroesophageal junction adenocarcinoma.\n\nAfter curative-intent surgery, patients remain at risk of disease recurrence. Postoperative treatment decisions are currently based on clinicopathological factors, which may not fully reflect minimal residual disease. ctDNA is a blood-based biomarker that can detect tumor-derived DNA fragments and may provide additional information on recurrence risk.\n\nIn this study, ctDNA will be assessed at predefined perioperative and postoperative time points using peripheral blood samples. The primary objective is to evaluate 1-year disease-free survival. Secondary objectives include survival outcomes, safety, and longitudinal changes in ctDNA status. The findings of this exploratory study may inform future research on ctDNA-guided postoperative management in gastric cancer.",[183,145,28,184],"ctDNA","Adjuvant Treatment","2026-03-30",{"date":187,"type":39},"2026-04-02",{"date":189,"type":21},"2026-04-01",{"date":191,"type":21},"2029-12-31",{"name":193,"class":194},"Fudan University","OTHER",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":227},"100594371","phase-2-an-open-label-phase-2-study-of-total-neoadjuvant-therapy-tnt-consisting-of-flot-with-pembrolizumab-and-short-radiation-for-patients-with-locally-advanced-gastroesophageal-junction-adenocarcinoma-100594371","NCT07018570","An Open Label Phase 2 Study of Total Neoadjuvant Therapy (TNT) Consisting of FLOT With Pembrolizumab and Short Radiation for Patients With Locally Advanced Gastroesophageal Junction Adenocarcinoma","\\\u003CInclusion Criteria\\>\n\n1. Patients with histologically confirmed esophagogastric junction adenocarcinoma.\n2. Patients who are naive to systemic therapy and have esophagogastric junction carcinoma of Siewert Type I to III classified as T: 2-4, N: any, and M: 0 according to the 8th edition of the UICC-TNM classification.\n3. Patients aged 18 years or older as of the day of informed consent.\n4. Patients with ECOG Performance Status (PS) 0 or 1.\n5. Patients whose most recent laboratory values within 14 days before registration meet all of the following criteria (testing on the same day of the week two weeks before the date of registration is acceptable).\n\n\\[1\\] Neutrophil count ≥1,500\u002Fmm3 \\[2\\] Hemoglobin ≥9.0 g\u002FdL \\[3\\] Platelet counts ≥100,000\u002Fmm3 \\[4\\] Total bilirubin ≤1.5 mg\u002FdL \\[5\\] AST (GOT) ≤100 IU\u002FL \\[6\\] ALT (GPT) ≤100 IU\u002FL \\[7\\] Serum creatinine ≤1.5 mg\u002FdL 6) Patients who did not receive blood transfusion within 7 days before registration (ineligible if transfusion was performed on the same day of the week one week before the date of registration).\n\n7)Female patients of childbearing potential who tested negative for pregnancy within 14 days before registration. Male and female patients who have agreed to practice appropriate highly effective contraception with low user dependency during the study and for up to 120 days after discontinuation of the investigational drug.\n\n8)Patients who have given consent to provide samples for biomarker analysis. 9)Patients who have given their own written consent to participate in the study\n\n\\\u003CExclusion Criteria\\>\n\n1. Patients with a history of using an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody.\n2. Patients with a history of acute coronary syndrome (including myocardial infarction and angina unstable), coronary angioplasty, or stent implantation within 6 months before registration.\n3. Patients with a history or findings of congestive heart failure of Class II or higher according to the New York Heart Association (NYHA) classification of cardiac function.\n4. Patient with active double cancers \\[simultaneous double cancers and metachronous double cancers with a disease-free interval of ≤2 years. However, carcinoma in situ or lesions equivalent to intramucosal carcinoma judged to have been cured by local treatment shall not be included in active double cancers\\].\n5. Patients with serious (requiring hospitalization) complications (e.g., intestinal paralysis, intestinal obstruction, pulmonary fibrosis, difficult-to-control diabetes mellitus, cardiac failure, myocardial infarction, angina unstable, renal failure, hepatic failure, psychiatric disorder, cerebrovascular disorder).\n6. Patients with active hepatitis B (HBs antigen positive) or hepatitis C.\n7. Patients with a history of HIV.\n8. Patients with complicated interstitial lung disease\u002Fpneumonitis or with a history of (non-infectious) interstitial lung disease\u002Fpneumonitis requiring steroid administration.\n9. Patients who received a live vaccine within 30 days before the start of investigational drug administration.\n10. Patients with concomitant autoimmune disease or a history of chronic or recurrent autoimmune disease.\n11. Patients who require systemic corticosteroids (except for prophylactic administration for testing or allergic reactions, or temporary use to reduce edema associated with radiotherapy) or immunosuppressive medication, or those who have received any of these treatments within 14 days before registration in this study.\n12. Patients with unhealed wounds (requiring sutures, antimicrobial administration, and cleaning procedures), ulcers, or fractures.\n13. Pregnant or lactating patients.\n14. Patients who are unwilling or unable to comply with the study protocol.\n15. Patients deemed by the investigator to be ineligible for this study.",{"count":202,"type":21},26,[24],"This study is to evaluate the effectiveness of treatment for esophagogastric junction carcinoma, total neoadjuvant therapy (TNT) including pembrolizumab and FLOT is conducted, aiming to choose between surgery or organ preservation treatment strategies.",[28],[207,208,209,210,211,212,213,214,215,216,217],"Esophagogastric junction carcinoma","Total neoadjuvant therapy","TNT","Radiation","Surgery","Pembrolizumab","FLOT","Chemotherapy","Non-operative management","QOL","Phase II","2025-08-25",{"date":220,"type":39},"2025-08-26",{"date":222,"type":39},"2025-07-24",{"date":224,"type":21},"2031-06",{"name":226,"class":194},"National Cancer Center Hospital East",1]