OncoMatch/Clinical Trials/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.
Is NCT06177041 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including M108 monoclonal antibody and Oxaliplatin for locally advanced unresectable or metastatic gastric cancer.
Treatment: M108 monoclonal antibody · Oxaliplatin · Capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: CLDN18 overexpression (positive)
Positive CDLN 18.2 expression
Required: HER2 (ERBB2) wild-type (negative)
Negative HER2 expression
Required: PD-L1 (CD274) overexpression (CPS<5)
PD-L1 CPS<5
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Exception: palliative radiotherapy to bone metastases and recovered from acute toxicity allowed
Previous radiotherapy within 4 weeks prior to the start of study treatment. (if palliative radiotherapy was given to bone metastases and the patient recovered from acute toxicity was allowed)
Cannot have received: anti-tumor therapy
Previous anti-tumor therapy within 4 weeks prior to the start of study treatment.
Cannot have received: CLDN18.2-targeted therapy
Subject who has been treated with CLDN18.2 monoclonal/bispecific antibodies, CLDN18.2 CAR-T, CLDN18.2 ADC and any therapies that target CLDN18.2.
Lab requirements
Blood counts
adequate haematological/coagulation function
Kidney function
adequate renal function
Liver function
adequate hepatic function
Adequate haematological/ coagulation/ hepatic/ renal function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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