[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637343":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":63,"collaborators":32,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":32,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":32,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":87,"whyStopped":32,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"FutureGen Biopharmaceutical (Beijing) Co., Ltd","INDUSTRY",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: FG-B901",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"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.",[13,22],"Drug: standard or investigator-determined chemotherapy",{"label":24,"type":10,"description":16,"interventionNames":25},"Combined-therapy Dose Expansion Cohort",[13,22],[27,33],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","FG-B901","Accelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles)",[19,24,9,15],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"standard or investigator-determined chemotherapy","standard or investigator-determined chemotherapy depending on the type of tumors.",[19,24],[38],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Zhaoyu Jin, Ph.D","CONTACT","010-60709130","pr@futuregenbiopharm.com",[44],{"facility":45,"status":32,"city":46,"state":32,"zip":32,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Fudan University Shanghai Cancer Center","Shanghai","China","CN",{"type":50,"coordinates":51},"Point",[52,53],121.45806,31.22222,{"lat":53,"lon":52},[56,60],{"name":57,"role":40,"phone":58,"phoneExt":32,"email":59},"Jian Zhang","+86-021-64175590","syner2000@163.com",{"name":61,"role":40,"phone":58,"phoneExt":32,"email":62},"Xianjun Yu","yuxianjun@fudanpci.org",{"type":64,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","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":76,"type":77},264,"ESTIMATED","INTERVENTIONAL",[80,81],"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).",[84],"Solid Tumor",[86],"CD40 agonist","NOT_YET_RECRUITING","2026-05-29",{"date":90,"type":91},"2026-06-03","ACTUAL",{"date":93,"type":77},"2026-07",{"date":95,"type":77},"2029-07",{"name":5,"class":6},1]