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. | Biotech Hunter

Enrollment

486

Participants

Timeline

Start Date

December 25, 2023

Primary Completion Date

January 11, 2027

Study Completion Date

April 11, 2027

Conditions

Locally Advanced Unresectable or Metastatic Gastric CancerLocally 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).

Trial Locations (1)

RECRUITING

Beijing Cancer Hospital, Beijing