A phase 3 trial testing M108 in gastric & gastro-oesophageal junction cancer, now recruiting.
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 a phase 3 interventional study registered as NCT06177041, led by FutureGen Biopharmaceutical (Beijing), and recruiting on the registry. Official title: A Phase 3, Multi-Center, Double-Blind, Randomised, 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. Planned enrolment is 486 participants (estimated). The study started in 2023-12-25 and primary completion is expected in 2027-01-11. No results have been posted on ClinicalTrials.gov.