RecruitingPhase 3NCT06177041

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.


Sponsor

FutureGen Biopharmaceutical (Beijing) Co., Ltd

Enrollment

486 participants

Start Date

Dec 25, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding M108 — a new experimental drug targeting Claudin 18.2, a protein found on some stomach cancer cells — to standard CAPOX chemotherapy improves outcomes compared to chemotherapy alone for people with advanced stomach or gastroesophageal junction cancer. **You may be eligible if...** - You are between 18 and 75 years old with locally advanced unresectable or metastatic stomach or gastroesophageal junction (GEJ) cancer confirmed by biopsy - Your tumor tests positive for Claudin 18.2 expression - Your tumor is HER2-negative and has low PD-L1 expression (CPS less than 5) - You have not received prior chemotherapy for your advanced/metastatic disease - You have adequate organ function and performance status of 0-1 **You may NOT be eligible if...** - Your tumor is HER2-positive or Claudin 18.2-negative - You have had prior radiotherapy within 4 weeks of starting the study - You are pregnant or breastfeeding - You have uncontrolled infections or significant heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGM108 monoclonal antibody

M108 monoclonal antibody will be administered as a minimum 2-hour IV infusion.

DRUGPlacebo

Placebo will be administered as a minimum 2-hour IV infusion.

DRUGOxaliplatin

Oxaliplatin will be administered as a 2-hour IV infusion.

DRUGCapecitabine

Capecitabine will be administered orally twice daily (bid).


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT06177041


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