Clinical Trial

Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

Active, Not Recruiting Phase 2
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Summary
This is a global, multicenter, randomized, open-label study. The main objective of the study is to measure the clinical activity and safety of zelenectide pevedotin formally BT8009, in combination with pembrolizumab versus chemotherapy, and as monotherapy in participants with locally advanced or metastatic urothelial cancer (UC). The study includes a dose selection for zelenectide pevedotin and is comprised of 2 cohorts. Cohort 1 will include participants who have not received any prior systemic therapy for locally advanced or metastatic UC and are eligible to receive platinum-based chemotherapy, whereas Cohort 2 will include participants who have received ≥ 1 prior systemic therapy for locally advanced or metastatic UC.
Protocol Amendment History 8 changes
critical Phase changed: Phase 2/3 -> Phase 2 2026-05-28
critical Primary endpoint(s) modified 2026-05-28
notable Enrollment reduced: 956 -> 375 participants 2026-05-28
minor Trial arms changed: 6 -> 5 2026-05-28
notable Primary completion moved earlier: 2030-12 -> 2028-03 2026-05-28
minor Completion moved earlier: 2030-12 -> 2028-03 2026-05-28
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-04-16
notable Trial sites reduced: 170 -> 104 locations 2026-04-16
Trial Details
NCT Number NCT06225596
Lead Sponsor BicycleTx Limited
Conditions Metastatic Urothelial Cancer
Enrollment 375 participants
Start Date 2024-01-24
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-05-27