eligibility_summary
Inclusion: la/mUC confirmed, tumor tissue available for biomarkers, prior AEs ≤G1. Part 1: prior platinum, ≤2 lines. Part 2: no prior systemic therapy. Exclusion: active second cancer, CNS mets/meningitis, ≥G2 neuropathy, severe ocular disease/keratitis/corneal ulcer, IBD needing immunosuppression, major CV/CVA disease, uncontrolled diabetes, recent investigational agent or live vaccine, Part 2: immunodeficiency/immunosuppression or active autoimmune, HIV with KS/MCD, active HBV/HCV, pneumonitis, active infection, prior allogeneic transplant, not recovered from major surgery.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests: 1) Sacituzumab tirumotecan (MK‑2870/SKB264) — a TROP‑2–targeted antibody‑drug conjugate (ADC) that binds TROP‑2 on tumor cells, is internalized, and releases a topoisomerase‑I inhibitor payload to induce DNA damage/apoptosis. 2) Enfortumab vedotin (EV, PADCEV) — a NECTIN‑4–targeted ADC delivering MMAE, a microtubule inhibitor causing cell‑cycle arrest and apoptosis. Originally planned Part 2: addition of pembrolizumab (MK‑3475, KEYTRUDA), an anti‑PD‑1 monoclonal antibody checkpoint inhibitor that blocks PD‑1/PD‑L1/PD‑L2 to reactivate T cells, however, Part 2 will not be conducted. Targets/pathways: TROP‑2 and NECTIN‑4 on urothelial carcinoma cells, topoisomerase‑I and microtubules, PD‑1 on T cells (if used).