eligibility_summary
Eligibility: ≥12‑wk life expectancy, measurable (RECIST 1.1), confirmed adv/metastatic UC, tissue available. C1: untreated, platinum‑eligible, only prior local tx ≥4 wk or neoadj/adj therapy with relapse >12 mo. C2: ≥1 prior systemic tx, progressed after last tx (incl relapse ≤12 mo post‑platinum). Exclude: active keratitis/corneal ulcer, strong CYP3A/P‑gp drugs, steroids >10 mg, allergy to study drugs/MMAE, recent major surgery, live vaccine <30 d, C1: CPI ≤12 mo, C2: >1 prior platinum or prior enfortumab/any MMAE.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06225596 (Duravelo-2) evaluates BT8009 (zelenectide pevedotin) as monotherapy or with pembrolizumab vs standard platinum chemotherapy ± avelumab in metastatic urothelial cancer. BT8009 is a Bicycle toxin conjugate (small bicyclic peptide–drug conjugate) that binds Nectin-4 on urothelial cancer cells and delivers the cytotoxic payload MMAE (microtubule inhibitor), causing mitotic arrest and apoptosis, targets: Nectin‑4–expressing tumor cells and microtubules. Pembrolizumab is an anti‑PD‑1 monoclonal antibody restoring T‑cell activity by blocking the PD‑1/PD‑L1 checkpoint, targets: PD‑1 pathway on T cells/tumor microenvironment. Comparator chemo: gemcitabine (nucleoside analog inhibiting DNA synthesis) plus cisplatin/carboplatin (DNA crosslinkers), targets: DNA replication/damage pathways in proliferating tumor cells. Maintenance avelumab is an anti‑PD‑L1 mAb targeting the PD‑1/PD‑L1 axis. Two cohorts: 1L platinum‑eligible and previously treated.