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

NCT07623707 | Not Yet Recruiting Phase 1

• 1 other identifier: FG-B901-01
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Solid Tumor

Keywords

CD40 agonist

Outcome Measures

Primary Outcomes (2)

• 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

• Maximum Tolerated Dose (MTD)

  MTD

  21 days

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  Up to 24 months

• Disease control rate (DCR)

  Up to 24 months

• Progression Free Survival (PFS)

  Up to 24 months

• Duration Of Response (DOR)

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

Study Arms (4)

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.

Drug: FG-B901

Monotherapy Dose Expansion Cohort

EXPERIMENTAL

Once the effective dose has been determined, 1\~2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose.

Drug: FG-B901

Combined-therapy Dose Escalation Cohort

EXPERIMENTAL

Three dose levels of FG-B901 will be tested according to an accelerated titration method followed by a adaptive BOIN design.

Drug: FG-B901; Drug: standard or investigator-determined chemotherapy

Combined-therapy Dose Expansion Cohort

EXPERIMENTAL

Once the effective dose has been determined, 1\~2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose.

Drug: FG-B901; Drug: standard or investigator-determined chemotherapy

Interventions

FG-B901 DRUG

Accelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles)

Combined-therapy Dose Escalation Cohort; Combined-therapy Dose Expansion Cohort; Monotherapy Dose Escalation Cohort; Monotherapy Dose Expansion Cohort

standard or investigator-determined chemotherapy DRUG

standard or investigator-determined chemotherapy depending on the type of tumors.

Combined-therapy Dose Escalation Cohort; Combined-therapy Dose Expansion Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ECOG performance status of 0 or 1;
• Expected survival ≥3 months;
• Have at least one measurable tumor lesion according to RECIST 1.1 criteria;
• Adequate cardiac, bone marrow, liver, renal function;

You may not qualify if:

• 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;
• Have received any clinical study drug treatment within 4 weeks prior to randomization;
• Have undergone major surgery within 4 weeks prior to randomization;
• Have a history of other (non-study tumor) malignancies within 3 years prior to randomization;
• Have received any organ transplant or bone marrow transplant;
• 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;
• Have experienced Grade ≥3 immune-related adverse events (irAEs) from prior immunotherapy;
• Have a history of severe allergic reactions or are allergic to the investigational drug (FG-B901);
• Have a history of central nervous system metastases and/or carcinomatous meningitis;
• Have adverse reactions from prior treatments that have not recovered to CTCAE v5.0 Grade ≤1 (excluding alopecia and anemia) prior to randomization;
• Have a history of severe respiratory disease;
• Have experienced a clinically significant cardiac disease within 6 months before the first dose of study drug;

Sponsors & Collaborators

• FutureGen Biopharmaceutical (Beijing) Co., Ltd: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Central Study Contacts

Zhaoyu Jin, Ph.D

CONTACT

010-60709130; pr@futuregenbiopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 3, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)