eligibility_summary
Include: adults >=18 with metastatic GI adenocarcinoma (gastroesophageal, colorectal, pancreaticobiliary) after standard therapy, adequate hematologic, hepatic, and renal function (CrCl >=30). Contraception required. Exclude: pregnant/breastfeeding, prior topo-I, investigational drugs, recent/unrecovered therapy, active 2nd malignancy, unstable brain mets, cardiac disease, active IBD or recent GI perforation, serious infection, HIV viremia or SN-38-interacting drugs, active HBV/HCV.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I single-arm (3+3) trial testing sacituzumab govitecan plus capecitabine in advanced GI cancers after standard therapy. Drugs/mechanisms: Sacituzumab govitecan is an antibody–drug conjugate (ADC) targeting Trop-2, its antibody binds Trop-2 on tumor cells and delivers SN-38 (topoisomerase I inhibitor), causing DNA strand breaks, S-phase arrest, and apoptosis. Capecitabine is an oral fluoropyrimidine prodrug of 5‑FU (antimetabolite) that inhibits thymidylate synthase, depletes dTMP, and disrupts DNA/RNA synthesis. Cells/pathways targeted: Trop-2–expressing epithelial cancer cells, topoisomerase I–dependent DNA replication/repair, pyrimidine synthesis via thymidylate synthase, with additional RNA/DNA incorporation effects of 5‑FU. Exploratory aim: correlate tumor Trop-2 expression with outcomes. Primary endpoint: RP2D, secondary: safety and antitumor activity.