eligibility_summary
Include: ≥18, unresectable/relapsed/metastatic gastric/GEJ adenocarcinoma after failed/intolerant 1L therapy, measurable RECIST 1.1, ECOG 0–1, ≥12‑wk survival, adequate marrow/organ, CLDN18.2+, CPS≥1, contraception. Exclude: recent studies/anticancer tx/radiation/surgery/stent/live vaccine, strong CYP3A4 inhibitors, uncontrolled infection/CNS mets, high bleed/TE risk, serious lung/heart/liver/GI disease, autoimmune/immunodeficiency/transplant, long‑term steroids, pregnancy, prior topo‑ADC, drug allergy/contraindication.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/interventions: IBI343 + sintilimab (IBI308). IBI343 is an antibody–drug conjugate (ADC) targeting CLDN18.2, it binds CLDN18.2 on tumor cells, is internalized, and releases a topoisomerase I–inhibiting cytotoxic payload to induce DNA damage and cell death (with potential bystander effect). Sintilimab is a monoclonal anti–PD-1 immune checkpoint inhibitor that restores T‑cell–mediated antitumor activity. Targeted cells/pathways: CLDN18.2-positive gastric/GEJ adenocarcinoma epithelial cells, DNA topoisomerase I pathway in tumor cells, PD‑1/PD‑L1 immune checkpoint on T cells within the tumor microenvironment. Exploratory: correlation of CLDN18.2 expression with response.