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Claudin 18.2Phase 1/2NCT07704866

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

A Phase 1/2 study testing FG-B901 and FG-M108 in people with Claudin 18.2 and Solid Tumor Malignancies, run by FutureGen Biopharmaceutical (Beijing) Co., Ltd at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Claudin 18.2, Solid Tumor Malignancies
What is being tested?
FG-B901 and FG-M108
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesChina
Study dates
30 Jul 2026to 28 Feb 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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
Show all 16Show fewer
  • 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
  • Known history of Hepatitis C or chronic active Hepatitis B

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhaoyu Jin Yu contact

+8610-60709130

pr@futuregenbiopharm.com

China2 sites

  • Harbin Medical University Cancer Hospital

    Ha’erbin

    Yanqiao Zhang, +8610-86298278, yanqiaozhanggcp@163.com

  • The First Hospital of China Medical University

    Shenyang

    Funan Liu, +8610-83282066, lfn540@126.com

Other trials in China

About this study

Official title: An Open-Label, Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FG-M108 Injection in Combination With FG-B901 Injection in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors

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.

Being tested
FG-B901, FG-M108

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FG-B901Drug

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

  • FG-B901Drug

    1~2 dose levels of FG-B901 will be tested according to an accelerated titration method followed by a adaptive BOIN design

  • FG-M108Drug

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

Study groups in NCT07704866
Study groupRoleWhat they receive
Dose Escalation CohortExperimentalExperimental : 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.
Receives: Drug: FG-B901; Drug: FG-M108
Dose Expansion CohortExperimentalOnce the effective dose has been determined, 1~2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose.
Receives: Drug: FG-B901; Drug: FG-M108

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 24 months

  2. 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.

    Measured: Up to 24 months

  3. 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.

    Measured: Up to 24 months

Secondary outcomes (7)

  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).

    Measured: Up to 24 months

  2. 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).

    Measured: Up to 24 months

  3. Overall Survival (OS)

    OS is defined as the time from randomization to deathdue to any cause.

    Measured: Up to 24 months

  4. Time to progression (TTP)

    TTP

    Measured: Up to 24 months

  5. Maximum measured plasma concentration of FG-B901 and FG-M108

    Cmax

    Measured: Up to 24 months

  6. Time to maximum plasma concentration of FG-B901 and FG-M108

    Tmax

    Measured: Up to 24 months

  7. Half-life of FG-B901 and FG-M108

    T1/2

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start30 Jul 2026 (estimated)
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07704866
Sponsor's protocol ID
FG-B901-02
Status last verified
Jul 2026
First submitted
10 Jul 2026
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing FG-B901 and FG-M108 in people with Claudin 18.2 and Solid Tumor Malignancies, run by FutureGen Biopharmaceutical (Beijing) Co., Ltd at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhaoyu Jin Yu (+8610-60709130, pr@futuregenbiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety assessed by Adverse Events (AEs) (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07704866.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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