eligibility_summary
Inclusion: Adults ≥18 with locally advanced/metastatic urothelial carcinoma, HER2 IHC 1+/2+/3+, no prior systemic therapy and cisplatin‑ineligible/refusing chemo, ECOG 0–1, ≥1 evaluable lesion, adequate organs, life expectancy ≥6 mo, consent/contraception/adherence. Exclusion: prior antitumor therapy, transplant, immunodeficiency, related drug allergy, HBV/HCV/HIV, recent live vaccine, NYHA III/IV, active infection, uncontrolled HTN/DM/ILD/COPD, recent steroids/immunosuppression, other cancer, pregnancy/lactation, other risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06178601 (Phase II, single-arm) tests RC48-ADC plus cadonilimab (AK104) in HER2-expressing locally advanced/metastatic urothelial carcinoma. RC48-ADC (disitamab vedotin) is a HER2-targeted antibody–drug conjugate: a monoclonal antibody binds HER2 (ERBB2) on tumor cells, is internalized, and releases MMAE (a microtubule inhibitor) to disrupt microtubules and induce apoptosis, potential bystander effect. Cadonilimab (AK104) is a tetravalent bispecific immune checkpoint monoclonal antibody blocking PD-1 and CTLA-4, enhancing effector T-cell activation and reducing Treg-mediated suppression in the tumor microenvironment. Targets/pathways: HER2 on tumor cells, microtubules, PD-1/PD-L1 and CTLA-4/CD80/CD86 on T cells/APCs. Both given IV Q2W.