eligibility_summary
Adults 18–80 with unresectable/metastatic gastric or GEJ adenocarcinoma, CLDN18.2+, HER2–, progressed after ≥2 systemic lines (neo/adjuvant within 6 mo counts as 1st), measurable (RECIST 1.1), ECOG 0–1, life ≥12 wks, adequate organs/coagulation, consent. Exclude: recent other cancers, immunodeficiency/transplant, significant proteinuria, major cardio/cerebrovascular disease, uncontrolled infection/ILD/pain, ≥G2 neuropathy, uncontrolled effusions, major surgery ±28 d, or per PI.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III, open-label, randomized study in CLDN18.2-positive, HER2-negative, locally advanced/metastatic gastric or GEJ adenocarcinoma after ≥2 prior lines. Interventions: 1) LM-302 (IV q2w), an investigational CLDN18.2-targeted antibody-based therapy (antibody-drug conjugate). Mechanism: binds claudin 18.2 on tumor cells, is internalized, and releases a cytotoxic payload to induce tumor cell death (may also engage immune effector functions). 2) Physician’s choice: apatinib or irinotecan. Apatinib: oral small-molecule VEGFR2 tyrosine kinase inhibitor, blocks VEGF signaling to inhibit angiogenesis (endothelial cells). Irinotecan: IV cytotoxic chemotherapy, inhibits topoisomerase I, causing DNA damage in proliferating tumor cells. Targets/pathways: CLDN18.2-positive tumor cells and VEGF/VEGFR angiogenic pathway.