[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637343":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":42,"studyPopulation":42,"armGroups":49,"interventions":68,"overallOfficials":42,"centralContacts":78,"locations":84,"responsibleParty":104,"collaborators":42,"id":106,"slug":42,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":42,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":42,"studyType":118,"phases":119,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":127,"whyStopped":42,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"FutureGen Biopharmaceutical (Beijing) Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":42},[9,13],{"measure":10,"description":11,"timeFrame":12},"Safety assessed by Adverse Events (AEs)","An AE is any adverse medical event that occurs during a clinical study, whether or not related with medicinal product, including signs, symptoms, abnormal laboratory test results and diseases. The incidence and severity of AEs during the clinical study are recorded and analyzed.","Up to 24 months",{"measure":14,"description":15,"timeFrame":16},"Maximum Tolerated Dose (MTD)","MTD","21 days",[18,21,24,27,30,33,36,39],{"measure":19,"description":20,"timeFrame":12},"Objective Response Rate (ORR)","ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.",{"measure":22,"description":23,"timeFrame":12},"Disease control rate (DCR)","DCR is defined as the proportion of participants who have a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as assessed by investigator evaluation per RECIST 1.1.",{"measure":25,"description":26,"timeFrame":12},"Progression Free Survival (PFS)","PFS is defined as the duration from randomization to the first imaging confirmation of progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first).",{"measure":28,"description":29,"timeFrame":12},"Duration Of Response (DOR)","DOR is defined as the time from the date of the first response (CR\u002FPR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or death due to any cause (whichever occurs first).",{"measure":31,"description":32,"timeFrame":12},"Overall Survival (OS)","OS is defined as the time from randomization to deathdue to any cause.",{"measure":34,"description":35,"timeFrame":12},"Maximum measured plasma concentration of FG-B901","Cmax",{"measure":37,"description":38,"timeFrame":12},"Time to maximum plasma concentration of FG-B901","Tmax",{"measure":40,"description":41,"timeFrame":12},"Half-life of FG-B901","T1\u002F2",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":42,"primaryPurpose":46,"observationalModel":42,"timePerspective":42,"maskingInfo":47},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":48,"maskingDescription":42,"whoMasked":42},"NONE",[50,56,60,65],{"label":51,"type":52,"description":53,"interventionNames":54},"Monotherapy Dose Escalation Cohort","EXPERIMENTAL","Nine dose levels of FG-B901 will be tested according to an accelerated titration method followed by a adaptive BOIN design.",[55],"Drug: FG-B901",{"label":57,"type":52,"description":58,"interventionNames":59},"Monotherapy Dose Expansion Cohort","Once the effective dose has been determined, 1\\~2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose.",[55],{"label":61,"type":52,"description":62,"interventionNames":63},"Combined-therapy Dose Escalation Cohort","Three dose levels of FG-B901 will be tested according to an accelerated titration method followed by a adaptive BOIN design.",[55,64],"Drug: standard or investigator-determined chemotherapy",{"label":66,"type":52,"description":58,"interventionNames":67},"Combined-therapy Dose Expansion Cohort",[55,64],[69,74],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":42},"DRUG","FG-B901","Accelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles)",[61,66,51,57],{"type":70,"name":75,"description":76,"armGroupLabels":77,"otherNames":42},"standard or investigator-determined chemotherapy","standard or investigator-determined chemotherapy depending on the type of tumors.",[61,66],[79],{"name":80,"role":81,"phone":82,"phoneExt":42,"email":83},"Zhaoyu Jin, Ph.D","CONTACT","010-60709130","pr@futuregenbiopharm.com",[85],{"facility":86,"status":42,"city":87,"state":42,"zip":42,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Fudan University Shanghai Cancer Center","Shanghai","China","CN",{"type":91,"coordinates":92},"Point",[93,94],121.45806,31.22222,{"lat":94,"lon":93},[97,101],{"name":98,"role":81,"phone":99,"phoneExt":42,"email":100},"Jian Zhang","+86-021-64175590","syner2000@163.com",{"name":102,"role":81,"phone":99,"phoneExt":42,"email":103},"Xianjun Yu","yuxianjun@fudanpci.org",{"type":105,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","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":116,"type":117},264,"ESTIMATED","INTERVENTIONAL",[120,121],"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).",[124],"Solid Tumor",[126],"CD40 agonist","NOT_YET_RECRUITING","2026-05-29",{"date":130,"type":131},"2026-06-03","ACTUAL",{"date":133,"type":117},"2026-07",{"date":135,"type":117},"2029-07",{"name":5,"class":6},1]