[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"FutureGen Biopharmaceutical (Beijing) Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100637343","phase-1-a-study-of-fg-b901-monotherapy-or-combination-with-chemotherapy-in-advanced-or-metastatic-solid-tumors-100637343",false,"NCT07623707","A Study of FG-B901 Monotherapy or Combination With Chemotherapy in Advanced or Metastatic Solid Tumors","An Open-Label, Multicenter Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FG-B901 Injection as Monotherapy and in Combination With Standard or Investigator-Determined Chemotherapy in Subjects With Unresectable Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Voluntarily sign the informed consent form, understand the study, are willing to comply with and have the ability to complete all trial procedures;\n* Age 18-75 years (inclusive), any gender;\n* Have histologically or cytologically confirmed locally advanced or metastatic solid tumors, and have failed standard therapy, or are intolerant to standard therapy, or for whom standard therapy is not available;\n* Able to provide tumor tissue specimens and peripheral blood samples that meet testing requirements, or provide prior test reports that meet the requirements;\n* ECOG performance status of 0 or 1;\n* Expected survival ≥3 months;\n* Have at least one measurable tumor lesion according to RECIST 1.1 criteria;\n* Adequate cardiac, bone marrow, liver, renal function;\n\nExclusion Criteria:\n\n* Have received a live vaccine within 3 months prior to randomization;\n* Have received radiotherapy within 4 weeks prior to randomization;\n* Have received other anti-tumor drug therapy within 4 weeks or within 5 half-lives of the anti-tumor drug prior to randomization;\n* Have undergone major surgery within 4 weeks prior to randomization;\n* Have received any clinical study drug treatment within 4 weeks prior to randomization;\n* Have undergone major surgery within 4 weeks prior to randomization;\n* Have a history of other (non-study tumor) malignancies within 3 years prior to randomization;\n* Have received any organ transplant or bone marrow transplant;\n* Have previously received any tumor necrosis factor receptor (TNFR) agonist antibody therapy, such as anti-CD40, anti-OX40, anti-CD137, anti-CD27, anti-CD357 antibodies, etc;\n* Have experienced Grade ≥3 immune-related adverse events (irAEs) from prior immunotherapy;\n* Have a history of severe allergic reactions or are allergic to the investigational drug (FG-B901);\n* Have a history of central nervous system metastases and\u002For carcinomatous meningitis;\n* Have adverse reactions from prior treatments that have not recovered to CTCAE v5.0 Grade ≤1 (excluding alopecia and anemia) prior to randomization;\n* Have a history of severe respiratory disease;\n* Have experienced a clinically significant cardiac disease within 6 months before the first dose of study drug;\n* Have uncontrolled systemic diseases assessed by the investigator, including diabetes, hypertension, pulmonary fibrosis, interstitial lung disease, etc.;\n* The investigator judges the subject to have obvious active gastrointestinal bleeding;\n* Known history of Hepatitis C or chronic active Hepatitis B;\n* Have experienced systemic treatment with corticosteroids within ≤2 weeks prior to randomization;\n* Any other condition of the subject (e.g., psychological, geographical, or medical condition) that does not permit compliance with the study and follow-up procedures;\n* Are pregnant or breastfeeding;","ALL","18 Years","75 Years",{"count":20,"type":21},264,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","FG-B901 is a recombinant humanized IgG2 bispecific antibody targeting PD-L1 and CD40. It is designed to provide PD-L1-dependent CD40 agonism, thereby enhancing selectivity for the tumor microenvironment and reducing systemic toxicity compared with conventional CD40 agonists. Preclinically, FG-B901 promotes antigen-presenting cell activation and synergizes with PD-L1\u002FPD-1 blockade to potentiate T-cell anti-tumor immunity. This is an open-label, multicenter phase I\u002FII trial in subjects with unresectable locally advanced or metastatic solid tumors. The primary objectives are to evaluate the safety, tolerability, and pharmacokinetics of FG-B901 as monotherapy and in combination with chemotherapy. Secondary objectives include preliminary anti-tumor efficacy (e.g., objective response rate, disease control rate, progression-free survival, and overall survival).",[28],"Solid Tumor",[30],"CD40 agonist","NOT_YET_RECRUITING","2026-05-29",{"date":34,"type":35},"2026-06-03","ACTUAL",{"date":37,"type":21},"2026-07",{"date":39,"type":21},"2029-07",{"name":41,"class":42},"FutureGen Biopharmaceutical (Beijing) Co., Ltd","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":43},"100622461","phase-3-a-study-of-fg-m108chemotherapy-vs-placebochemotherapy-in-claudin182-positive-pancreatic-cancer-100622461","NCT07383922","A Study of FG-M108+Chemotherapy vs Placebo+Chemotherapy in Claudin18.2-positive Pancreatic Cancer","A Randomized, Double-blind, Placebo-controlled Phase 3 Study Comparing the Efficacy and Safety of FG-M108 Versus Placebo Combined With Standard Chemotherapy in First-line Treatment of Patients With Claudin18.2-Positive Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* Voluntarily sign the informed consent form, understand the study, are willing to comply with and have the ability to complete all trial procedures;\n* Age 18-80 years (inclusive), any gender;\n* Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, without prior systemic therapy; or for subjects who have received prior neoadjuvant\u002Fadjuvant chemotherapy, the time from the last treatment to disease recurrence is \\>6 months;\n* Able to provide archived or fresh pathological tissue for CLDN18.2 testing, with central laboratory testing confirming tumor tissue CLDN18.2 positive (defined as ≥40% of tumor cells with CLDN18.2 membrane staining ≥2+ by central laboratory IHC);\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* Have at least one measurable tumor lesion according to RECIST 1.1 criteria;\n* Expected survival ≥3 months;\n* Adequate cardiac, bone marrow, liver, renal function;\n\nExclusion Criteria:\n\n* Have received a live vaccine within 4 weeks prior to randomization;\n* Have received radiotherapy within 2 weeks prior to randomization;\n* Have received other anti-tumor drug therapy within 4 weeks or within 5 half-lives of the anti-tumor drug prior to randomization;\n* Have undergone major surgery within 4 weeks prior to randomization;\n* Have received any clinical study drug treatment within 4 weeks prior to randomization;\n* Have previously received any treatment targeting CLDN18.2, such as CLDN18.2 monoclonal\u002Fbispecific antibodies, CLDN18.2 CAR-T, or CLDN18.2 ADC;\n* Have a history of other (non-study tumor) malignancies within 3 years prior to randomization;\n* Have a history of central nervous system metastases and\u002For carcinomatous meningitis;\n* Have adverse reactions from prior treatments that have not recovered to CTCAE v5.0 Grade ≤1 (excluding alopecia and anemia) prior to randomization;\n* Have had clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to randomization;\n* Have uncontrolled systemic diseases assessed by the investigator, including diabetes, hypertension, pulmonary fibrosis, interstitial lung disease, etc.;\n* The investigator judges the subject to have obvious active gastrointestinal bleeding;\n* Known history of Hepatitis C or chronic active Hepatitis B;\n* Require systemic treatment with corticosteroids (dose \\>10 mg\u002Fday prednisone or equivalent dose of similar drugs) or other immunosuppressants within ≤14 days prior to randomization;\n* Any other condition of the subject (e.g., psychological, geographical, or medical condition) that does not permit compliance with the study and follow-up procedures;\n* Are pregnant or breastfeeding;","80 Years",{"count":53,"type":21},524,[55],"PHASE3","Pancreatic cancer, which stands as one of the most lethal malignancies and a leading cause of cancer-related deaths globally, poses a significant challenge to human health worldwide. However, standard chemotherapeutic regimens show limited effectiveness in advanced pancreatic cancer, creating an urgent demand to investigate and develop novel therapeutic targets and combination treatment strategies. The primary objective of this study is to evaluate the efficacy of FG-M108 combined with gemcitabine and nab-paclitaxel (Nab-P+GEM) versus placebo combined with Nab-P+GEM as first-line treatment, as measured by overall survival (OS). This study will also assess safety, tolerability, pharmacokinetics, and the immunogenicity profile of FG-M108 monoclonal antibody, along with its impact on quality of life.",[58],"Pancreatic Cancer",[60,61,62],"Pancreatic cancer","First-line treatment","Claudin18.2","2026-02-02",{"date":65,"type":35},"2026-02-04",{"date":67,"type":21},"2026-02-28",{"date":69,"type":21},"2030-12-31",{"name":41,"class":42},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":43},"100529689","phase-3-m108-plus-capox-versus-placebo-plus-capox-as-first-line-treatment-for-claudin-cldn-182-positive-her2-negative-pd-l1-cps5-locally-advanced-unresectable-or-metastatic-gastric-or-gastroesophageal-junction-gej-adenocarcinoma-100529689","NCT06177041","M108 Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS\u003C5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.","A Phase 3, Multi-Center, Double-Blind, Randomized, Efficacy and Safety Study of M108 Monoclonal Antibody Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS\u003C5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.","Inclusion Criteria:\n\n1. Written informed consent\n2. Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric\u002FGEJ adenocarcinoma with no treatment previously. For patients with neoadjuvant\u002Fadjuant chemotherapy in the past, duration of last therapy to recurrence should be more than 6 months\n3. At least 1 measurable site of the disease according to RECIST 1.1 criteria.\n4. Positive CDLN 18.2 expression\n5. Negative HER2 expression, PD-L1 CPS\\\u003C5\n6. ECOG performance status (PS) 0-1\n7. Life expectancy \\> 3 months\n8. Age ≥ 18 years and ≤75 years\n9. Adequate haematological\u002F coagulation\u002F hepatic\u002F renal function\n10. Men and women of childbearing age should agree to use effective contraception from the time they sign their informed consent until 3 months after the last dosing. Female subjects of childbearing age must have a negative blood beta-HCG test within 72 hours prior to first dosing.\n\nExclusion Criteria:\n\n1. Previous radiotherapy within 4 weeks prior to the start of study treatment. (if palliative radiotherapy was given to bone metastases and the patient recovered from acute toxicity was allowed).\n2. Previous anti-tumor therapy within 4 weeks prior to the start of study treatment.\n3. Previous major operation within 4 weeks prior to the start of study treatment.\n4. Have a prior severe allergic reaction or intolerance to known components of M108 monoclonal antibodies or other monoclonal antibodies (including humanized or chimeric antibodies); Allergic or intolerant to any component of capecitabine, oxaliplatin, etc.\n5. Subject who has been treated with CLDN18.2 monoclonal\u002Fbispecific antibodies, CLDN18.2 CAR-T, CLDN18.2 ADC and any therapies that target CLDN18.2.\n6. Subject who is in pregnant or in lactation period.\n7. Other clinically significant disease which may have adversely affected the safe delivery of treatment within this study.",{"count":79,"type":21},486,[55],"Gastric\u002FGEJ adenocarcinoma, which is one of the major leading causes of cancer-related deaths worldwide, is a global challenge to human health. However, standard chemotherapy has limited efficacy in advanced gastric cancer, and there is an urgent need to explore and develop new therapeutic targets and combination therapy modalities. The main purpose of this study is to explore the efficacy of M108 monoclonal antibody plus capecitabine and oxaliplatin (CAPOX) versus placebo plus CAPOX as first-line treatment measured by progression free survival (PFS). This study will also evaluate safety, tolerability, pharmacokinetics and the immunogenicity profile of M108 monoclonal antibody, as well as its effects on quality of life.",[83,84],"Locally Advanced Unresectable or Metastatic Gastric Cancer","Locally Advanced Unresectable or Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma","RECRUITING","2024-02-25",{"date":88,"type":35},"2024-02-28",{"date":90,"type":35},"2023-12-25",{"date":92,"type":21},"2027-04-11",{"name":41,"class":42},""]