Clinical Trial

A Study of FG-B901 Monotherapy or Combination With Chemotherapy in Advanced or Metastatic Solid Tumors

Not Yet Recruiting Phase 1/2
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Summary
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/PD-1 blockade to potentiate T-cell anti-tumor immunity. This is an open-label, multicenter phase I/II 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).
Trial Details
NCT Number NCT07623707
Lead Sponsor FutureGen Biopharmaceutical (Beijing) Co., Ltd
Conditions Solid Tumor
Enrollment 264 participants
Start Date 2026-07
Primary Completion 2027-12 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-03