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

An Open-Label, Multicenter Phase I/II 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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: FG-B901; Drug: standard or investigator-determined chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Zhaoyu Jin, Ph.D; Phone Number: 010-60709130; Email: pr@futuregenbiopharm.com

Study Locations

• China
  • Shanghai, China
    • Fudan University Shanghai Cancer Center
    • Contact: Xianjun Yu; Phone Number: +86-021-64175590; Email: yuxianjun@fudanpci.org
    • Contact: Jian Zhang; Phone Number: +86-021-64175590; Email: syner2000@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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;
• Have uncontrolled systemic diseases assessed by the investigator, including diabetes, hypertension, pulmonary fibrosis, interstitial lung disease, etc.;
• The investigator judges the subject to have obvious active gastrointestinal bleeding;
• Known history of Hepatitis C or chronic active Hepatitis B;
• Have experienced systemic treatment with corticosteroids within ≤2 weeks prior to randomization;
• 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;
• Are pregnant or breastfeeding;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: FG-B901; Accelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles)
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.	Drug: FG-B901; Accelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles)
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.	Drug: FG-B901; Accelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles); Drug: standard or investigator-determined chemotherapy; standard or investigator-determined chemotherapy depending on the type of tumors.
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.	Drug: FG-B901; Accelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles); Drug: standard or investigator-determined chemotherapy; standard or investigator-determined chemotherapy depending on the type of tumors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization to deathdue to any cause.	Up to 24 months
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).	Up to 24 months
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.	Up to 24 months
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.	Up to 24 months
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).	Up to 24 months
Maximum measured plasma concentration of FG-B901	Cmax	Up to 24 months
Time to maximum plasma concentration of FG-B901	Tmax	Up to 24 months
Half-life of FG-B901	T1/2	Up to 24 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: CD40 agonist
• Other Study ID Numbers: FG-B901-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No