eligibility_summary
Eligibility: Adults (≥18) with ECOG 0–1 and histologically confirmed unresectable/metastatic gastric or GEJ adenocarcinoma, CLDN18.2-positive, progressed after ≥2 systemic lines (≤4 total, neoadjuvant/adjuvant ending ≤6 months before relapse counts as 1st), able to consent. Exclude: HER2-positive, in another interventional study, prior topoisomerase inhibitor–based ADCs, recent therapy (<4 weeks/5 half-lives), or planned concurrent therapy (palliative RT allowed).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 randomized, open-label trial in previously treated CLDN18.2-positive, HER2‑negative gastric/GEJ adenocarcinoma comparing IBI343 vs investigator’s choice (irinotecan, paclitaxel, or trifluridine/tipiracil). IBI343 (arcotatug tavatecan) is an antibody–drug conjugate targeting Claudin 18.2, upon binding to CLDN18.2 on tumor cells it internalizes and releases a topoisomerase I–inhibitor payload, causing DNA damage/apoptosis (potential Fc‑mediated ADCC/CDC). Irinotecan: cytotoxic camptothecin/topoisomerase I inhibitor. Paclitaxel: taxane microtubule stabilizer blocking mitosis. Trifluridine/tipiracil: oral nucleoside analog (FTD) incorporated into DNA plus TPI to prevent FTD degradation. Targets/pathways: CLDN18.2+ gastric tumor cells, topo I–dependent DNA replication/repair, microtubules, DNA synthesis.