NCT07383922

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 524 (estimated)
• Sponsor: FutureGen Biopharmaceutical (Beijing) Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-28
• Primary completion: 2030-06-30
• Completion: 2030-12-31
• First posted: 2026-02-03
• Last updated: 2026-02-04

Locations

1 site across 1 country: China