[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-or-metastatic-solid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-or-metastatic-solid-tumor":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,82,111],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100409902","phase-1-study-of-sacituzumab-govitecan-in-participants-with-advanced-or-metastatic-solid-tumor-and-moderate-liver-impairment-100409902",false,"NCT04617522","Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment","A Phase 1, Open-Label, Dose-Escalation Study to Determine an Appropriate Starting Dose of Sacituzumab Govitecan in Subjects With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment","Key Inclusion Criteria for all Individuals:\n\n* Histologically confirmed advanced or metastatic solid tumor that is measurable or nonmeasurable.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n* Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g\u002FdL, absolute neutrophil count (ANC) ≥1,500\u002Fmm\\^3, and platelets ≥ 100,000\u002F μL).\n* Creatinine clearance ≥ 30 mL\u002Fmin as assessed by the Cockcroft-Gault equation.\n\nKey Inclusion Criteria for Individuals with Normal Hepatic Function:\n\n* Normal hepatic function (total bilirubin ≤ ULN and aspartate aminotransferase (AST) ≤ 3.0× ULN).\n\nKey Inclusion Criteria for Individuals with Moderate Hepatic Function:\n\n* Moderate hepatic impairment (1.5 × ULN \\\u003C total bilirubin ≤ 3.0 × ULN and any level of AST).\n* For individuals with hepatic encephalopathy, the condition does not, in the Investigator's opinion, interfere with the individual's ability to provide an appropriate informed consent.\n\nKey Exclusion Criteria for all Individuals:\n\n* Have poor venous access.\n* Donated or lost 500mL or more of blood volume (including plasmapheresis) to plans to donate during the study.\n* Have had a prior anticancer biologic agent within 4 weeks prior to Day 1 or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Day 1 and who have not recovered (i.e., ≤ Grade 1) from adverse events (AEs) at the time of study entry. Individuals participating in observational studies are eligible.\n* Had prior treatment with irinotecan within 4 weeks prior to Day 1.\n* Have not recovered (i.e., ≤ Grade 1) from AEs due to a previously administered agent.\n* Have an active second malignancy.\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking \\\u003C 20 mg\u002Fday of prednisone or its equivalent. All individuals with carcinomatous meningitis are excluded regardless of clinical stability.\n* Have history of cardiac disease.\n* Have active chronic inflammatory bowel disease (ulcerative colitis or Crohn's disease) or gastrointestinal (GI) perforation within 6 months of enrollment.\n* Have active serious infection (Contact medical monitor for clarification).\n* High-dose systemic corticosteroids (≥20 mg of prednisone or its equivalent) are not allowed within 2 weeks of Check-In. However, inhaled, intranasal, intra-articular, and topical steroids are allowed.\n* Use of strong inhibitor or inducer of UGT1A1.\n* Have a known history of Gilbert's disease.\n\nKey Exclusion Criteria for Individuals with Normal Hepatic Impairment:\n\n* Must have pre-existing condition interfering with hepatic and\u002For renal function that could interfere with the metabolism and\u002For excretion of the study drug.\n\nKey Exclusion Criteria for Individuals with Moderate Hepatic Impairment:\n\n* Had a significant clinical exacerbation of liver disease symptoms within the 2-week period before administration of study drug (i.e., abdominal pain, nausea, vomiting, anorexia, or fever).\n* Had clinically demonstrable, tense ascites.\n* Had evidence of acute viral hepatitis within 1 month prior to administration of study drug.\n* Have evidence of hepatorenal syndrome.\n* Individuals with transjugular intrahepatic portosystemic shunt (TIPS) placement.\n* Have active Stage 3 or 4 encephalopathy.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goals of this clinical study are to learn more about the safety and dosing of the study drug, sacituzumab govitecan-hziy, in participants with solid tumors and moderate liver problems.",[26,27],"Advanced or Metastatic Solid Tumor","Liver Failure","RECRUITING","2026-06-01",{"date":31,"type":32},"2026-06-02","ACTUAL",{"date":34,"type":32},"2021-04-06",{"date":36,"type":20},"2026-12",{"name":38,"class":39},"Gilead Sciences","INDUSTRY",15,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":53,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100536890","phase-1-a-phase-1-study-of-pln-101095-in-adults-with-advanced-or-metastatic-solid-tumors-100536890","NCT06270706","A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors","A Phase 1a\u002F1b Multicenter, Open-label Dose Escalation\u002FExpansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on an Immune Checkpoint Inhibitor (FORTIFY)","Inclusion Criteria:\n\n1. Has histologically or cytologically confirmed advanced or metastatic solid tumor\n2. Have received ≥12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment administered as monotherapy or in combination with other anticancer therapies\n3. Have demonstrated documented prior clinical benefit, defined as CR or PR at any time during treatment, or SD lasting ≥6 months (Part 2 only)\n4. Must have subsequently developed radiographic disease progression while receiving anti-PD-1 or anti-PD-L1 treatment or within ≤12 weeks after the last dose of such treatment\n5. At least 1 measurable lesion, as defined by RECIST v1.1\n6. Estimated survival of ≥3 months\n7. Have adequate bone marrow and organ function.\n8. A female participant is eligible to participate if she is not pregnant, not breastfeeding\n\nExclusion Criteria:\n\n1. Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab\n2. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years\n3. Has received prior radiotherapy within 2 weeks for palliative bone-directed therapy and 4 weeks for all other radiotherapy\n4. Has undergone major surgery within 4 weeks prior to the first dose of study treatment or has not adequately recovered from surgery or related complications\n5. Has a diagnosis of immunodeficiency or use of systemic steroids \\>10 mg\u002Fday\n6. Has an active autoimmune disease that has required systemic treatment in the past 2 years\n7. Has known active CNS metastases (brain and\u002For leptomeningeal metastases)\n8. Has significant cardiac disease\n9. Has an active infection requiring systemic therapy (including uncontrolled HIV, Hepatitis B and C)\n10. Has received a live or live-attenuated vaccine within 30 days or a non-live vaccine within 7 days prior to the first dose of PLN-101095",{"count":49,"type":20},124,[23],"This is a Phase 1a\u002F1b, dose-escalation\u002Fexpansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory \\[primary resistance\\]) or relapsed \\[secondary resistance\\]) after at least 3 months from the start of treatment with pembrolizumab.\n\nThe study will consist of 2 main parts:\n\n* Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design with accelerated titration\n* Part 2: Dose-expansion cohorts using Simon's 2-stage design",[26],[54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71],"Advanced Solid Tumors Cancer","Anal Carcinoma","Biliary tract carcinoma (BTC)","Cholangiocarcinoma","Clear cell renal cell carcinoma (ccRCC)","Colorectal Cancer","Endometrial Cancer","Gallbladder","Head and Neck Squamous Cell Cancer (HNSCC)","Melanoma","Non-small cell lung cancer (NSCLC)","Ovarian Carcinoma","Triple Negative Breast Cancer (TNBC)","Tumor mutational burden (TMB)-high tumors","TMB-low tumors","Urothelial Carcinoma","Pembrolizumab","Immunotherapy","2026-04-15",{"date":74,"type":32},"2026-04-20",{"date":76,"type":32},"2023-08-30",{"date":78,"type":20},"2030-06",{"name":80,"class":39},"Pliant Therapeutics, Inc.",6,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100439243","phase-1-ab122-platform-study-100439243","NCT04999761","AB122 Platform Study","Platform Study of AB122 Based Treatments in Patients with Advanced Solid Tumors","Inclusion Criteria:\n\n* Is male or female aged ≥ 18 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedures (except for Cohort E-2);\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 before administration of study treatment;\n* Has adequate organ function as defined by the following criteria:\n\n  * AST and ALT ≤ 3 × ULN; or if a patient with documented liver metastases, AST and ALT ≤ 5 × ULN\n  * T-Bil of ≤ 1.5 × ULN\n  * ANC ≥ 1500 \u002Fmm3 (ie, ≥ 1.5 × 109 \u002FL by International System of Units \\[SI\\]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor \\[G-CSF\\])\n  * Platelet count ≥ 100000 \u002Fmm3 (SI: ≥ 100 × 109 \u002FL) (excluding measurements obtained within 7 days after a transfusion of platelets)\n  * Hemoglobin value of ≥ 9.0 g\u002FdL excluding measurements within 4 weeks after a transfusion of packed red blood cells (RBCs) or whole blood\n* Has a life expectancy of at least 90 days;\n\nCohort A-1 and A-2\n\n* Japanese male and female;\n* Has a histologically or cytologically confirmed diagnosis of solid tumor;\n* Has disease progression after standard treatment for advanced or metastatic disease, are intolerant to the standard treatment;\n\nCohort B-1\n\n* Has a histologically or cytologically confirmed diagnosis of PDAC;\n* Has disease progression after or intolerant to one prior systemic chemotherapy for advanced or metastatic disease\n\nCohort B-2\n\n* Has a histologically or cytologically confirmed diagnosis of CRC.\n* Has been received one regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the chemotherapy\n\nCohort B-3 - Has a histologically or cytologically confirmed non-squamous NSCLC;\n\n* Has been received one or two regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the standard treatment\n* Has been most recently received regimen including an ICI (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies) and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotherapy followed by checkpoint inhibitor therapy), and all of the following criteria must be met:\n\n  * Received at least 2 doses at the most recent ICI therapy\n  * Radiographic complete response or partial response based on investigator assessment with ICI therapy\n  * Documented radiographic disease progression with above most recently received regimen\n\nCohort C-1\n\n* Has unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer as pathologically confirmed adenocarcinoma\n* Gastroesophageal junction cancer is defined as a tumor with an epicenter that is located within 2 cm proximal to and distal from the esophagogastric junction (the boundary of esophageal and gastric muscularis).\n* Has received 2-4 standard regimens listed below and has demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose (The patient is eligible if the treatment is discontinued owing to SAEs, allergic reactions, or neurotoxicities.):\n\n  * fluoropyrimidines and platinum\n  * taxane or irinotecan\n  * ramucirumab\n\nCohort C-2\n\n* Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded)\n* RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy; Wild type is defined as v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) (exon 2, 3 and 4) and neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS) (exon 2, 3 and 4) wild type. \\[Mutant is defined as at least KRAS or NRAS mutant (any exon, any mutation)\\].\n* Has received at least 2 prior chemotherapy regimens for the treatment of advanced CRC and had demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose , or intolerance to their last regimen, and all of the following criteria must be met:\n\n  * Prior treatment regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody\n  * For RAS wild-type patients, an anti-EGFR monoclonal antibody must have included in addition to above\n\nCohort D-1\n\n* Has histologically confirmed advanced or metastatic NSCLC regardless of histologic type.\n* Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory.\n\nCohort D-2\n\n* Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-3\n\n* Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.\n* No prior therapy for advanced or metastatic disease, or refractory or intolerant to at least 1 cycle of standard first-line therapy.\n\n  * Treatment discontinued due to intolerable toxicity or because the same drug cannot be re-treated before the disease progresses is considered as intolerable to the previous treatment.\n  * Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-4\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\n  * The confirmed status of the human papillomavirus (HPV) in cancers of the mid-pharynx.\n  * Patient background such as combined positive score (CPS) and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort D-5\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\n  * The confirmed status of the HPV in cancers of the mid-pharynx.\n  * Patient background such as CPS and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort D-6\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous NSCLC.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-7\n\n* Has histologically confirmed unresectable or advanced biliary tract cancer (intrahepatic bile duct, extrahepatic bile duct, gallbladder, or duodenal papillary region) with a diagnosis of adenocarcinoma or adenosquamous carcinoma.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-8\n\n* Has histologically confirmed unresectable or advanced pancreatic ductal adenocarcinoma (highly differentiated, moderately differentiated, or poorly differentiated).\n* No prior therapy for advanced or metastatic disease. Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort E-1\n\n* Has a histologically or cytologically confirmed advanced or metastatic NSCLC regardless of histologic type.\n* Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory (except for tolerability part).\n* Has been received 1-4 regimen for advanced or metastatic disease\n* Has been received one regimen of ICI monotherapy or combination therapy (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies), and all of the following criteria must be met:\n\n  * Received at least 2 doses of the ICI therapy\n  * Documented radiographic disease progression with or after ICI therapy\n\nCohort E-2\n\n* Has a histologically or cytologically confirmed advanced or metastatic ASPS\n* Is male or female aged ≥ 16 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedure\n\nExclusion Criteria:\n\n* History or current evidence of cardiac arrhythmia and\u002For conduction abnormality: Any factor that can increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, etc.;\n* Treatment with any of the following within the specified time frame prior to the day on which study treatment is scheduled to be started:\n\n  * Major surgery within 4 weeks (the surgical incision should be fully healed prior to the day on which study treatment is scheduled to be started);\n  * Extended-field radiotherapy within 4 weeks or limited-field radiotherapy within 2 weeks;\n  * Any anticancer therapy within 2 weeks;\n  * Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever shorter;\n* Unresolved toxicity of ≥ Grade 2 attributed to any prior therapies (excluding anemia, peripheral sensory neuropathy, alopecia and skin pigmentation);\n* A serious illness or medical condition(s) including, but not limited to, the following specific medical conditions:\n\n  * Known acute systemic infection;\n  * Known medical history of interstitial lung disease\u002F drug-induced interstitial lung disease\u002F radiation pneumonitis which required steroid treatment\u002F any evidence of clinically active interstitial lung disease;\n  * Myocardial infarction, severe\u002Funstable angina, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV, Appendix A) within the previous 6 months; if \\> 6 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms;\n  * Known severe chronic kidney disease;\n  * Known positivity of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody in baseline virus test. In addition, the patient who is known negative in HCV ribonucleic acid (RNA) is eligible, even if positive for HCV antibody;\n  * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment, or may interfere with the interpretation of study results, and in the judgment of the investigator or sub-investigator would make the patient inappropriate for entry into this study;\n* Previous or concurrent cancer that is distinct in primary disease or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (stage Ta, Tis and T1), cancers corresponding to intraepithelial or intramucosal neoplasia, or any cancer curatively treated \\> 5 years prior to the day on which study treatment is scheduled to be started;\n* WOCBP or male patients who do not agree to effective birth control during the following period\n\n  1. WOCBP patients: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;\n  2. Male patients with WOCBP partners: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;\n* Prior treatment with an anti-PD-L1 anti-PD-1, anti-CTLA-4, or other ICI or agonist as monotherapy or in combination (except for cohort B-3, C-1, D-1 tolerability part and E-1).\n* Has received a live vaccine within 30 days prior to study treatment including, but not limited to the following examples: measles, mumps, rubella, varicella-zoster, yellow fever, and BCG. The inoculation with inactivated vaccines for seasonal influenza is allowed.\n* 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 to enrollment.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 28 days 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 enrollment.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient\\'s participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. (eg, paresis of intestine, intestinal obstruction, unable to receive 5% dextrose in water \\[DW\\] in patients with diabetes mellitus, respiratory failure, renal failure, hepatic failure, cerebrovascular disorder, gastrointestinal ulcers that require transfusion or are hemorrhagic, and wounds\u002Fbone fractures associated with neovascularization during the healing process, accumulation of pleural within 2 weeks prior to enrollment, ascitic, or pericardial fluid requiring drainage)",{"count":90,"type":20},917,[23],"This is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.",[26,94,59,95,96,97,98,99,100],"Pancreatic Ductal Adenocarcinoma","Non-small Cell Lung Cancer","Gastric Cancer","Alveolar Soft Part Sarcoma","Esophageal Cancer","Head and Neck Cancer","Biliary Tract Cancer","2024-09-23",{"date":103,"type":32},"2024-09-25",{"date":105,"type":32},"2021-06-01",{"date":107,"type":20},"2026-05",{"name":109,"class":39},"Taiho Pharmaceutical Co., Ltd.",9,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":129,"locationsCount":131},"100436577","phase-1-treatment-of-advanced-and-metastatic-solid-tumors-with-mil97-100436577","NCT04965077","Treatment of Advanced and Metastatic Solid Tumors With MIL97","A Phase I Multicenter, Open Label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MIL97 in Subjects With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Adult patients, \\>=18 years of age;\n2. Diagnosis of Refractory\u002Frelapsed metastatic and\u002For unresectable solid tumors;\n3. At least one extracranial measurable unirradiated lesion or evaluable lesion (recist v1.1) ;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Life expectancy \\>=3 months;\n5. Sufficient organ and bone marrow function within 7 days before enrollment;\n6. Life expectancy \\>=12 weeks;\n7. Able and willing to provide written informed consent and to comply with the study protocol.\n\nExclusion Criteria:\n\n1. have a history of myocardial infarction within 6 months or a history of arterial thromboembolic event within 3 months before the first dose;\n2. Comorbidity that would interfere with therapy, including interstitial pneumonia, symptomatic congestive heart failure; unstable angina, uncontrolled hypertension; ongoing cardiac arrhythmia ≥ CTCAE 5.0 Grade 3, active coagulopathy, uncontrolled diabetes, QTcF\\>450ms (Male) or QTcF\\>470ms (Female) at screening;\n3. Patients have a known or suspected history of an autoimmune disorder, except for the following: Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders such as vitiligo, or alopecia not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are eligible;\n4. Have a history of manifested central nervous system (CNS) metastases or have primary brain tumor. Patients with known or suspected leptomeningeal disease or cord compression;\n5. Receipt of allograft or allogeneic hematopoietic stem cell transplantation;\n6. Patients have another active invasive malignancy, but history of a non-invasive malignancy and history of malignancy that is in complete remission after treatment with curative intent are allowed;\n7. Active known clinically serious infections are required intravenous antibiotic treatment;\n8. Have a history of primary immunodeficiency, including but not limited with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness;\n9. Active and clinical significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C (HCV) (Hepatitis B should be confirmed as HBV surface antigen (HBsAg) positive or HBV core antibody (HBcAb) positive with HBV DNA above ULN);\n10. Any antitumor therapy within prior 4 weeks (including chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy, tumor embolization, etc), except for palliative radiotherapy for relief bone pain;\n11. Major surgery within prior 4 weeks or expected to require major surgery during study treatment (Major surgery: laparotomy, thoracotomy, and internal organs excision by laparoscopic surgery);\n12. Patients have concurrent received or used an immunosuppressive agent within 14 days before study treatment, with the following exceptions and notes: Systemic steroids at physiologic doses, intranasal, inhaled, topical, intra-articular, and ocular corticosteroids with minimal systemic absorption, transient courses of steroids may be approved by the Medical Monitor;\n13. Previous exposure to CD40 antibodies;\n14. Patients received a live attenuated vaccine within 28 days before study treatment and plan to receive live vaccines during the study unless approved by both investigator and sponsor;\n15. Toxicities due to prior therapy are unresolved to ≤ CTCAE 5.0 Grade 1 except for AEs not constituting a safety risk to the patient based on the judgment of investigators;\n16. History of clinically significant sensitivity or allergy to MIL97, their excipients, or intravenous gamma globulin;\n17. Females who are pregnant or lactating or who intend to become pregnant during the clinical trial period and within 6 months after discontinuation of study treatment. Female or Male who refused using birth control during the clinical trial period and within 6 months after discontinuation of study treatment;\n18. Participation in a therapeutic clinical study within 4 weeks for biological treatments, and within 1 week or 5 half-lives for small-molecule agents, before study drug treatment, or current participation in other therapeutic investigational procedures;\n19. Patients who have any clinically significant psychiatric, social, or medical condition that, in the opinion of the investigator, could increase the patient's risk, interfere with protocol adherence, or affect the patient's ability to give informed consent are ineligible to participate in the study.",{"count":119,"type":20},62,[23],"This is a Phase 1, global, multi-center, open-label, multiple-dose, first-in-human study of MIL97 to evaluate the safety, tolerability, pharmacokinetics, biomarkers and efficacy in subjects with advanced or metastatic solid tumor. The study consists of a dose escalation phase and a dose expansion phase. An accelerated titration design (cohorts 1-2 only) followed by 3+3 dose-escalation design will be used in dose escalation phase.\n\nThe starting dose for dose escalation phase is 0.01 mg\u002Fkg Q3W, followed by 5 dose cohorts (0.03mg\u002Fkg Q3W, 0.1mg\u002Fkg Q3W, 0.2mg\u002Fkg Q3W, 0.3mg\u002Fkg Q3W and 0.45mg\u002Fkg Q3W). Duration of dose limiting toxicity (DLT) observation is 21 days. Based on data of 3-week treatment regimen, one or two dose levels may be chosen for Q2w regimen. Duration of dose limiting toxicity (DLT) observation is 28 days.\n\nOne or two dose cohorts will be chosen (either 2-week regimen or 3-week regimen cohorts) to expand to total of 10 subjects in each cohort for further exploration of PK as well as safety and efficacy.",[26],"2024-03-11",{"date":125,"type":32},"2024-03-13",{"date":127,"type":32},"2022-01-18",{"date":36,"type":20},{"name":130,"class":39},"Beijing Mabworks Biotech Co., Ltd.",1]