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

NCT07383922 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: FG-M108-06
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancer; First-line treatment; Claudin18.2

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

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

  Up to 24 months

Secondary Outcomes (5)

• Progression Free Survival (PFS)

  Up to 24 months

• Objective Response Rate (ORR)

  Up to 24 months

• Disease control rate (DCR)

  Up to 24 months

• Duration Of Response (DOR)

  Up to 24 months

• Safety assessed by Adverse Events (AEs)

  Up to 24 months

Study Arms (2)

FG-M108 + Chemotherapy

EXPERIMENTAL

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; Drug: nab paclitaxel; Drug: Gemcitabine (GEM)

Placebo + Chemotherapy

ACTIVE COMPARATOR

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; Drug: Gemcitabine (GEM); Drug: Placebo for FG-M108

Interventions

FG-M108 DRUG

FG-M108 monoclonal antibody will be administered as a minimum 2-hour Intravenous drip.

Also known as: M108

FG-M108 + Chemotherapy

Gemcitabine (GEM) DRUG

Gemcitabine will be administered as an Intravenous drip.

Also known as: Gemcitabine Hydrochloride

FG-M108 + Chemotherapy; Placebo + Chemotherapy

Placebo for FG-M108 DRUG

Placebo will be administered as an Intravenous drip.

Placebo + Chemotherapy

nab paclitaxel DRUG

Nab-paclitaxel will be administered as an Intravenous drip.

Also known as: Albumin-bound paclitaxel

FG-M108 + Chemotherapy; Placebo + Chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 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 18-80 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Taxes; Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Zhaoyu Jin, Ph.D

  FutureGen Biopharmaceutical (Beijing) Co., Ltd

  STUDY CHAIR

Central Study Contacts

Zhaoyu Jin, Ph.D

CONTACT

010-60709130; pr@futuregenbiopharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

CN (1)