eligibility_summary
Adults (≥18, >35 kg) with untreated unresectable/metastatic gastric or GEJ adenocarcinoma, measurable disease (RECIST 1.1), ECOG 0–1, life expectancy ≥12 weeks, adequate organ/bone marrow function, central lab–confirmed CLDN18.2 from recent archival or fresh biopsy. Excludes HER2+ or indeterminate disease, active/progressive CNS mets, uncontrolled ascites, active TB/HIV/hepatitis, uncontrolled illness, autoimmune needing immunosuppression, other malignancy, prior IO, prior CLDN18.2/MMAE.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, multi‑arm study in unresectable/metastatic gastric/GEJ adenocarcinoma testing: (1) Volrustomig (bispecific anti‑PD‑1/CTLA‑4 mAb, IV) + XELOX or FOLFOX, (2) Rilvegostomig (bispecific anti‑PD‑1/TIGIT mAb, IV) + XELOX or FOLFOX, (3) AZD0901 (anti‑Claudin18.2 antibody–drug conjugate, IV) + Volrustomig + 5‑FU or capecitabine, (4) AZD0901 + Rilvegostomig + 5‑FU or capecitabine, (5) AZD7789 (bispecific anti‑PD‑1/TIM‑3 mAb, IV) + XELOX or FOLFOX, (6) AZD0901 + AZD7789 + 5‑FU or capecitabine. Mechanisms/targets: checkpoint blockade restores anti‑tumor T/NK cell function by inhibiting PD‑1, CTLA‑4, TIGIT, TIM‑3, AZD0901 targets Claudin18.2 on tumor cells to deliver cytotoxic payload, chemotherapies target proliferating tumor cells (5‑FU/capecitabine—antimetabolites, oxaliplatin—DNA crosslinker, leucovorin potentiates 5‑FU).