eligibility_summary
Adults (≥18) with path-confirmed, inoperable advanced colorectal cancer, measurable disease (RECIST v1.1), prior oxaliplatin, irinotecan, and 5-FU (progressed/intolerant), prior anti-HER2 allowed, HER2 IHC 2+/3+, ECOG 0–2, life expectancy ≥12 weeks, contraception and consent required. Exclude: allergy to anti‑HER2 MMAE ADC, significant/uncontrolled cardiac disease, bevacizumab contraindications, recent major surgery/trauma, other serious risks per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm trial in metastatic colorectal cancer with HER2 expression (IHC 2+ or 3+) after standard therapy failure. Intervention: RC48-ADC (disitamab vedotin), an anti-HER2 antibody–drug conjugate (humanized IgG1 linked via val-cit to MMAE, a microtubule inhibitor), plus bevacizumab, an anti-VEGF-A monoclonal antibody. Mechanisms: RC48-ADC binds HER2 (ERBB2) on tumor cells, is internalized, and releases MMAE to inhibit tubulin polymerization, causing mitotic arrest/apoptosis, may also exert Fc-mediated effects. Bevacizumab neutralizes VEGF-A, blocking VEGFR signaling and tumor angiogenesis. Targets/pathways: HER2+ colorectal cancer cells, microtubule dynamics, VEGF/VEGFR-driven endothelial pathways and tumor vasculature. Dosing: RC48-ADC IV with bevacizumab 5 mg/kg every 2 weeks. Primary endpoint: ORR, secondary: PFS, OS, safety. Two cohorts by HER2 level (low vs high).