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).
Voluntarily sign the informed consent form, understand the study, are willing to comply with and have the ability to complete all trial procedures;
Age 18-75 years (inclusive), any gender;
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;
Able to provide tumor tissue specimens and peripheral blood samples that meet testing requirements, or provide prior test reports that meet the requirements;
Have received a live vaccine within 3 months prior to randomization;
Have received radiotherapy within 4 weeks prior to randomization;
Have received other anti-tumor drug therapy within 4 weeks or within 5 half-lives of the anti-tumor drug prior to randomization;
Have undergone major surgery within 4 weeks prior to randomization;
Sequential
FG-B901
DrugAccelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles)
standard or investigator-determined chemotherapy
Drugstandard or investigator-determined chemotherapy depending on the type of tumors.
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.
Maximum Tolerated Dose (MTD)
MTD
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.
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.
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).
Duration Of Response (DOR)
DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or death due to any cause (whichever occurs first).
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