eligibility_summary
Adults 18–75 with untreated unresectable/metastatic gastric or GEJ adenocarcinoma, measurable disease (RECIST 1.1), CLDN18.2+, HER2−, PD‑L1 CPS<5, ECOG 0–1, life expectancy >3 mo, adequate organ function. Prior neoadj/adjuvant allowed if relapse >6 mo. Exclude recent (<4 wk) RT/therapy/major surgery, prior CLDN18.2‑targeted tx, severe drug allergies, pregnancy/lactation, serious comorbidity. Contraception/consent, women need negative pregnancy test.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3, double-blind, first-line study in CLDN18.2-positive, HER2-negative, PD-L1 CPS<5 gastric/GEJ adenocarcinoma comparing M108 + CAPOX vs placebo + CAPOX. Interventions and mechanisms: • M108: targeted immunotherapy, a monoclonal antibody against Claudin 18.2 that binds tumor cell tight-junction protein to promote immune effector killing (ADCC/CDC) and disrupt CLDN18.2-mediated signaling on cancer cells. • Capecitabine: oral antimetabolite (prodrug of 5-FU) that inhibits thymidylate synthase and interferes with DNA/RNA synthesis. • Oxaliplatin: platinum chemotherapeutic that forms DNA crosslinks leading to apoptosis. Cells/pathways targeted: CLDN18.2-expressing gastric/GEJ tumor cells, Fc receptor–mediated cytotoxicity via NK cells/macrophages, DNA synthesis and repair pathways (thymidylate synthase, DNA crosslink repair). Primary endpoint: PFS.