A Phase I/II Study of FG-M108 Plus FG-B901 in Advanced CLDN18.2-Positive Solid Tumors

NCT07704866 | Not Yet Recruiting Phase 1

• 1 other identifier: FG-B901-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

This open-label, multicenter Phase I/II trial evaluates the combination of FG-M108 and FG-B901 in patients with unresectable locally advanced or metastatic solid tumors that are positive for Claudin 18.2 and have progressed on, are intolerant to, or lack standard therapy. The Phase I dose-escalation part (using a BF-BOIN design) assesses safety, tolerability, and pharmacokinetics, and determines the recommended Phase II dose (RP2D) of FG-B901 when given with fixed-dose FG-M108. The Phase IIa expansion cohorts, grouped by tumor type, further evaluate safety and preliminary efficacy, with antitumor activity measured by RECIST 1.1 and iRECIST, while also exploring biomarker correlates. Key eligibility requires CLDN18.2 positivity (≥10% tumor cells with ≥1+ membrane staining by IHC), ECOG performance status 0-1, and measurable disease. Up to approximately 30 participants will be enrolled per cohort in Phase IIa. The study aims to provide initial evidence on the combination's safety, tolerability, PK, immunogenicity, and clinical activity in this hard-to-treat population.

Conditions

Claudin 18.2; Solid Tumor Malignancies

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (7)

• Progression Free Survival (PFS)

  Up to 24 months

• Duration Of Response (DOR)

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

• Time to progression (TTP)

  Up to 24 months

• Maximum measured plasma concentration of FG-B901 and FG-M108

  Up to 24 months

Study Arms (2)

Dose Escalation Cohort

EXPERIMENTAL

Experimental : Monotherapy Dose Escalation Cohort Eight dose levels of FG-B901 combined with fixed-dosed FG-M108 will be tested according to an accelerated titration method followed by a adaptive BOIN design.

Drug: FG-B901; Drug: FG-M108

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: FG-M108

Interventions

FG-B901 DRUG

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

Dose Escalation Cohort

FG-M108 DRUG

300 mg/m2, IV infusion Q3W (21-day cycles)

Dose Escalation Cohort; 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;
• CLDN18.2 positive (defined as ≥10% of tumor cells showing membrane staining ≥1+ by central laboratory IHC)
• ECOG 0-1
• 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 the first dose;
• Received radiotherapy within 4 weeks before the first dose
• Received Chinese herbal medicine with antitumor indications within 2 weeks before the first dose
• Previously received any therapy targeting CLDN18.2
• History of other malignancies within 3 years before the first dose
• Experienced Grade ≥3 immune-related adverse events (irAEs) from prior immunotherapy or discontinued immunotherapy due to irAEs, or have irAEs from prior immunotherapy that the investigator judges to still have clinical impact
• Toxicity from prior antitumor therapy has not recovered to NCI CTCAE v5.0 Grade 0-1
• History of severe allergic reactions, or hypersensitivity, or intolerance to any known component of the investigational products or other monoclonal antibodies
• Have brain or leptomeningeal metastases with symptoms
• Presence of clinically symptomatic body cavity effusions (pleural effusion, ascites, pericardial effusion, etc.) requiring local therapy or repeated drainage, or effusions that are poorly controlled per investigator judgment
• Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases
• Clinically uncontrolled diseases such as diabetes, thyroid disorders (hormone replacement therapy does not affect enrollment), or other severe systemic diseases requiring systemic treatment
• Active or progressive infection requiring systemic treatment within 2 weeks before the first dose
• Known or suspected active autoimmune disease requiring systemic treatment
• Pregnant or breastfeeding female participants

Sponsors & Collaborators

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

Study Sites (2)

Harbin Medical University Cancer Hospital

Ha’erbin, China

Location

The First Hospital of China Medical University

Shenyang, China

Location

Central Study Contacts

Zhaoyu Jin Yu

CONTACT

+8610-60709130; 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: July 10, 2026
• First Posted: July 15, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

CN (2)