eligibility_summary
Include: Adults with high‑grade upper‑tract urothelial carcinoma T2–T4a N0/x M0 and positive cytology, cisplatin‑ineligible (CrCl 30–<60, ≥G2 hearing loss, or declined), KPS ≥70, surgical candidates, adequate labs, tumor tissue available, controlled HIV allowed. Exclude: metastases, systemic/RT for bladder UC ≤2y, ≥G2 neuropathy, active eye ulcers, uncontrolled diabetes, major CV events/CHF, bleeding/coagulopathy, recent major surgery, active TB/HBV/HCV, prior enfortumab, pregnancy/breastfeeding, severe allergy, noncompliance, inadequate contraception.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05868265: single-arm phase 2 neoadjuvant study in high-grade upper tract urothelial carcinoma (cisplatin-ineligible or declining). Intervention: enfortumab vedotin (EV) 1.25 mg/kg on days 1 and 8 every 21 days for 3 cycles, then radical surgery. EV is an antibody–drug conjugate (immunoconjugate): an anti–Nectin-4 IgG1 monoclonal antibody linked via a protease-cleavable linker to monomethyl auristatin E (MMAE), a microtubule-disrupting cytotoxin. Mechanism: EV binds Nectin-4 on tumor cells, is internalized, and releases MMAE to inhibit tubulin polymerization, inducing mitotic arrest and apoptosis, Fc-mediated effector functions may contribute. Targets: Nectin-4–expressing urothelial cancer cells, microtubule/mitotic and apoptotic pathways.