eligibility_summary
Adults 18–75 with ECOG 0–1, ≥12-week survival, advanced/metastatic gastric or GEJ adenocarcinoma after ≤2 lines, measurable disease, adequate organs, tumor tissue with moderate–high CLDN18.2, agree to contraception. Exclude: pregnancy, active HBV/HCV/HIV, immunodeficiency/transplant, prior CLDN18.2/MMAE ADCs, recent investigational drug/vaccine/therapy, unresolved toxicities, infections/effusions, major comorbid CV/QT/bleeding/TE/autoimmune, unstable brain mets, other cancer <5y, recent surgery, Phase II ICI/VEGF rules, poor adherence.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I/II trial in CLDN18.2-positive, locally advanced/metastatic solid tumors (focus on gastric/GEJ) tests: 1) RC118, an antibody–drug conjugate (ADC) targeting Claudin 18.2, after binding and internalization, it releases the MMAE cytotoxic payload to disrupt microtubules, causing mitotic arrest/apoptosis of CLDN18.2+ tumor cells. 2) Toripalimab, an anti‑PD‑1 IgG4 monoclonal antibody checkpoint inhibitor that blocks PD‑1/PD‑L1 signaling to restore cytotoxic T‑cell activity. 3) RC148, a sponsor checkpoint‑inhibitor monoclonal antibody (exact target not specified in the record) used as an alternative to toripalimab in Phase II. Cells/pathways targeted: CLDN18.2-expressing tumor cells, microtubule dynamics (MMAE), and the PD‑1 immune‑checkpoint pathway on T cells.