eligibility_summary
Adults 18–80 with untreated LA/M urothelial cancer, ECOG 0–1, measurable disease, adequate tissue/organ function, cis/carboplatin-eligible, life expectancy >12 wks. Exclude: recent other cancer, autoimmune on systemic therapy, major cardio/cerebrovascular disease/thrombosis, recent surgery/radiation/vaccines/strong CYP3A4/TCM, active infection, prior ICIs or Nectin-4/MMAE ADCs, transplant, ≥G2 tox or neuropathy, uncontrolled CNS mets, active HBV/HCV/HIV, allergy or substance/psychiatric issues.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 first-line trial in unresectable/metastatic urothelial carcinoma. Experimental: 9MW2821 (Bulumtatug fuvedotin), a Nectin‑4–targeting antibody–drug conjugate (ADC) delivering MMAE, a microtubule‑disrupting cytotoxic, plus toripalimab, a PD‑1–blocking monoclonal antibody (immune checkpoint inhibitor). Comparator: gemcitabine (nucleoside analog antimetabolite inhibiting DNA synthesis) plus cisplatin or carboplatin (platinum DNA crosslinkers). Targets/pathways: Nectin‑4 on urothelial tumor cells with intracellular MMAE‑mediated microtubule disruption and apoptosis, PD‑1/PD‑L1 axis on T cells to restore antitumor immunity, and, in control, DNA replication (gemcitabine) and DNA crosslink/repair pathways (platinum agents).