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

Sponsor
FutureGen Biopharmaceutical (Beijing) Co., Ltd
Study ID
NCT07623707
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • FG-B901 — DRUG
    Accelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles)
  • standard or investigator-determined chemotherapy — DRUG
    standard or investigator-determined chemotherapy depending on the type of tumors.

Study Details

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).

Key Dates

First listed
Jun 3, 2026
Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
264 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy Dose Escalation Cohort
    Nine dose levels of FG-B901 will be tested according to an accelerated titration method followed by a adaptive BOIN design.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: Combined-therapy 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.

Primary Outcome Measure

Safety assessed by Adverse Events (AEs) [ Time Frame: Up to 24 months ]

Central Contacts

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