{"entity":{"id":"nct06177041","kind":"trial","name":"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","aka":[],"tldr":"A phase 3 trial testing M108 in gastric & gastro-oesophageal junction cancer, now recruiting.","summary":"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.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06177041","url":"https://clinicaltrials.gov/study/NCT06177041"}],"tags":["ctgov-ingest"],"related":[],"cancers":["gastric"],"sections":[],"technologies":[],"targets":[],"drugs":["m108"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06177041","phase":"3","setting":"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)","started":"2023-12-25","startedType":"actual","enrolled":486,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06177041/","neighbours":{"cancer":[{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"}],"drug":[{"id":"m108","kind":"drug","name":"M108","route":"/drugs/m108/"}]}}