eligibility_summary
Eligible: 18–80, ECOG 0–1, life ≥3 mo, advanced CLDN18.2+ GI cancer post failed/intolerant 1L, measurable disease, adequate labs. Exclude: HER2+ GC/GEJ, recent trials/tx or unresolved AEs, severe irAEs/immune myocarditis, neuropathy ≥2, uncontrolled pain, CNS mets, or effusions, CYP3A4 strong meds/live vax, ILD/pneumonitis, severe GI events or recent major surgery, other cancer ≤2 y, severe CV/illness, immunosuppression/autoimmune/immunodef, HIV/HBV/HCV, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05934331 tests LM-302 combinations in CLDN18.2-positive advanced GI cancers. Interventions and mechanisms: - LM-302: CLDN18.2-targeting antibody-drug conjugate (ADC), binds CLDN18.2 on tumor cells, internalizes, and delivers a cytotoxic payload to kill cancer cells. - Toripalimab, Nivolumab: anti–PD-1 monoclonal antibodies, release T-cell inhibition via PD-1/PD-L1 axis to enhance antitumor immunity. - Capecitabine and Tegafur/Gimeracil/Oteracil (S-1): oral fluoropyrimidine antimetabolites, generate 5-FU to inhibit thymidylate synthase and DNA synthesis, gimeracil inhibits DPD, oteracil limits GI toxicity. - Gemcitabine: nucleoside antimetabolite, inhibits ribonucleotide reductase and DNA chain elongation. - Apatinib: small-molecule VEGFR2 TKI, blocks VEGF signaling to inhibit tumor angiogenesis. Targets: CLDN18.2+ tumor cells, PD-1 pathway on T cells, DNA synthesis pathways in tumor cells, and VEGF/VEGFR2 in endothelial cells.