eligibility_summary
Adults (≥18) with unresectable/metastatic gastric or GEJ adenocarcinoma, CLDN18.2 IHC ≥10%, measurable disease (RECIST 1.1), ECOG 0–1, >3-month survival, adequate renal/liver/marrow. Prior adjuvant/neoadjuvant allowed if >6 months and oxaliplatin toxicity resolved. Exclude: HER2+, recent surgery/radiation, autoimmune/pneumonitis, CHF/CAD, stroke, bleeding/clot, perforation, HIV, active HBV/HCV (unless controlled), severe lung disease/ILD, other active cancer, pregnancy/lactation, psychiatric illness, steroids/immunosuppression, immunodeficiency/transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions and mechanisms: LM-302 is an antibody–drug conjugate (ADC) targeting CLDN18.2, delivering the microtubule inhibitor monomethyl auristatin E (MMAE, vedotin) to induce direct cytotoxicity, bystander killing, and Fc-mediated ADCC. Cadonilimab (AK104) is a bispecific immune checkpoint antibody blocking PD-1 and CTLA-4 to reinvigorate T-cell anti-tumor activity. Capecitabine is an oral 5-FU prodrug (antimetabolite chemotherapy) that inhibits thymidylate synthase and DNA/RNA synthesis. Targets/pathways: CLDN18.2 on tumor cells, microtubules (MMAE), Fc–effector cell ADCC, PD-1 and CTLA-4 on T cells, nucleotide synthesis via 5-FU. Phase II, single-arm with safety lead-in.