A Study of FG-M108+Chemotherapy vs Placebo+Chemotherapy in Claudin18.2-positive Pancreatic Cancer

February 2, 2026 updated by: FutureGen Biopharmaceutical (Beijing) Co., Ltd

A Randomized, Double-blind, Placebo-controlled Phase 3 Study Comparing the Efficacy and Safety of FG-M108 Versus Placebo Combined With Standard Chemotherapy in First-line Treatment of Patients With Claudin18.2-Positive Advanced Pancreatic Cancer

Pancreatic cancer, which stands as one of the most lethal malignancies and a leading cause of cancer-related deaths globally, poses a significant challenge to human health worldwide. However, standard chemotherapeutic regimens show limited effectiveness in advanced pancreatic cancer, creating an urgent demand to investigate and develop novel therapeutic targets and combination treatment strategies. The primary objective of this study is to evaluate the efficacy of FG-M108 combined with gemcitabine and nab-paclitaxel (Nab-P+GEM) versus placebo combined with Nab-P+GEM as first-line treatment, as measured by overall survival (OS). This study will also assess safety, tolerability, pharmacokinetics, and the immunogenicity profile of FG-M108 monoclonal antibody, along with its impact on quality of life.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled phase 3 study designed to evaluate the efficacy and safety of FG-M108 injection combined with Nab-P+GEM versus placebo combined with Nab-P+GEM as first-line treatment in patients with Claudin18.2-positive, unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.

Study Type

Interventional

Enrollment (Estimated)

524

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 18-80 years (inclusive), any gender;
  • Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, without prior systemic therapy; or for subjects who have received prior neoadjuvant/adjuvant chemotherapy, the time from the last treatment to disease recurrence is >6 months;
  • Able to provide archived or fresh pathological tissue for CLDN18.2 testing, with central laboratory testing confirming tumor tissue CLDN18.2 positive (defined as ≥40% of tumor cells with CLDN18.2 membrane staining ≥2+ by central laboratory IHC);
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
  • Have at least one measurable tumor lesion according to RECIST 1.1 criteria;
  • Expected survival ≥3 months;
  • Adequate cardiac, bone marrow, liver, renal function;

Exclusion Criteria:

  • Have received a live vaccine within 4 weeks prior to randomization;
  • Have received radiotherapy within 2 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 previously received any treatment targeting CLDN18.2, such as CLDN18.2 monoclonal/bispecific antibodies, CLDN18.2 CAR-T, or CLDN18.2 ADC;
  • Have a history of other (non-study tumor) malignancies within 3 years prior to randomization;
  • 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 had clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to randomization;
  • 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;
  • Require systemic treatment with corticosteroids (dose >10 mg/day prednisone or equivalent dose of similar drugs) or other immunosuppressants within ≤14 days 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FG-M108 + Chemotherapy
FG-M108 300mg/m2 Intravenous drip, day1, every 3 weeks Nab-paclitaxel 125mg/m2 Intravenous drip, day1, 8, every 3 weeks Nab-paclitaxel 125mg/m2 Intravenous drip, day1, 8, every 3 weeks
Drug: FG-M108
FG-M108 monoclonal antibody will be administered as a minimum 2-hour Intravenous drip.
Other Names:
  • M108
Drug: nab paclitaxel
Nab-paclitaxel will be administered as an Intravenous drip.
Other Names:
  • Albumin-bound paclitaxel
Drug: Gemcitabine (GEM)
Gemcitabine will be administered as an Intravenous drip.
Other Names:
  • Gemcitabine Hydrochloride
Active Comparator: Placebo + Chemotherapy
Placebo 300mg/m2 Intravenous drip, day1, every 3 weeks Nab-paclitaxel 125mg/m2 Intravenous drip, day1, 8, every 3 weeks Nab-paclitaxel 125mg/m2 Intravenous drip, day1, 8, every 3 weeks
Drug: nab paclitaxel
Nab-paclitaxel will be administered as an Intravenous drip.
Other Names:
  • Albumin-bound paclitaxel
Drug: Gemcitabine (GEM)
Gemcitabine will be administered as an Intravenous drip.
Other Names:
  • Gemcitabine Hydrochloride
Drug: Placebo for FG-M108
Placebo will be administered as an Intravenous drip.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 24 months
OS is defined as the time from randomization to deathdue to any cause.
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Up to 24 months
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)
Time Frame: Up to 24 months
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)
Time Frame: Up to 24 months
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)
Time Frame: Up to 24 months
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
Safety assessed by Adverse Events (AEs)
Time Frame: Up to 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FutureGen Biopharmaceutical (Beijing) Co., Ltd

Investigators

  • Study Chair: Zhaoyu Jin, Ph.D, FutureGen Biopharmaceutical (Beijing) Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 28, 2026

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG-M108-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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