eligibility_summary
Eligibility: Patients with high‑risk NMIBC (transitional cell, mixed allowed if TCC predominant), BCG‑treated and failed (salvage arm), ineligible/declining cystectomy, HER2 IHC 2+/3+, ECOG 0–2, life expectancy ≥12 wks, adequate organ function, tumor tissue available, consent, women negative pregnancy test, contraception required. Exclude muscle‑invasive/metastatic or extravesical disease, recent trials/intravesical therapy, drug allergy, active other cancer (<5y), active autoimmune (≤2y), severe comorbidities, prior allogeneic transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II multicenter trial in high-risk HER2+ non–muscle-invasive bladder cancer testing RC48-ADC (disitamab vedotin), an antibody–drug conjugate: a humanized anti-HER2 IgG1 linked to the cytotoxic payload MMAE (microtubule inhibitor). Mechanism: RC48 binds HER2 (ERBB2) on urothelial tumor cells, is internalized, and releases MMAE to disrupt tubulin polymerization, causing G2/M arrest and apoptosis, Fc region may trigger ADCC and bystander killing. Dosing: 2.0 mg/kg IV every 2 weeks for 12 weeks as adjuvant or salvage (post-BCG failure). Targets: HER2-overexpressing bladder cancer cells, pathways: HER2/ERBB2 signaling, mitotic microtubules/tubulin, immune effector (ADCC).