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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.

NCT06177041 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 486

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

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

Interventions

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).

Sponsors & Collaborators

  • FutureGen Biopharmaceutical (Beijing) Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-12-25
Primary Completion
2027-01-11
Completion
2027-04-11

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT06177041 on ClinicalTrials.gov