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

NCT07383922 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 524

Last updated 2026-02-04

No results posted yet for this study

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

Interventions

DRUG

FG-M108

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

DRUG

nab paclitaxel

Nab-paclitaxel will be administered as an Intravenous drip.

DRUG

Gemcitabine (GEM)

Gemcitabine will be administered as an Intravenous drip.

DRUG

Placebo for FG-M108

Placebo will be administered as an Intravenous drip.

Sponsors & Collaborators

  • FutureGen Biopharmaceutical (Beijing) Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zhaoyu Jin, Ph.D · FutureGen Biopharmaceutical (Beijing) Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2030-06-30
Completion
2030-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07383922 on ClinicalTrials.gov