NCT06177041

M108 Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.

A Phase 3, Multi-Center, Double-Blind, Randomized, Efficacy and Safety Study of M108 Monoclonal Antibody Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 486 (estimated)
• Sponsor: FutureGen Biopharmaceutical (Beijing) Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Gastric/GEJ adenocarcinoma, which is one of the major leading causes of cancer-related deaths worldwide, is a global challenge to human health. However, standard chemotherapy has limited efficacy in advanced gastric cancer, and there is an urgent need to explore and develop new therapeutic targets and combination therapy modalities. The main purpose of this study is to explore the efficacy of M108 monoclonal antibody plus capecitabine and oxaliplatin (CAPOX) versus placebo plus CAPOX as first-line treatment measured by progression free survival (PFS). This study will also evaluate safety, tolerability, pharmacokinetics and the immunogenicity profile of M108 monoclonal antibody, as well as its effects on quality of life.

Detailed description

The aim of this phase 3, double-blind, randomized, placebo-controlled study is to explore the efficacy and safety of M108 monoclonal antibody plus chemotherapy versus placebo plus chemotherapy as first-line treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS\<5, locally advanced or metastatic gastric/GEJ adenocarcinoma. Patients will be randomized in a 1:1 ration to receive M108 monoclonal antibody plus chemotherapy or placebo plus chemotherapy.

Conditions

• Locally Advanced Unresectable or Metastatic Gastric Cancer
• Locally Advanced Unresectable or Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

Interventions

Type	Name	Description
DRUG	M108 monoclonal antibody	M108 monoclonal antibody will be administered as a minimum 2-hour IV infusion.
DRUG	Placebo	Placebo will be administered as a minimum 2-hour IV infusion.
DRUG	Oxaliplatin	Oxaliplatin will be administered as a 2-hour IV infusion.
DRUG	Capecitabine	Capecitabine will be administered orally twice daily (bid).

Timeline

• Start date: 2023-12-25
• Primary completion: 2027-01-11
• Completion: 2027-04-11
• First posted: 2023-12-20
• Last updated: 2024-02-28

Locations

1 site across 1 country: China