Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
Running, not enrolling · Phase 2
Conditions studied: Metastatic Urothelial Cancer
In brief
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.
Key facts
- Study ID
- NCT06225596
- Run by
- BicycleTx Limited
- People needed
- 375
- Starts
- 2024-01-24
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-05-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Miami - Sylvester Comprehensive Cancer Center — Miami, Florida, United States
- Mount Sinai Medical Center of Florida, Inc. — Miami Beach, Florida, United States
- Moffitt — Tampa, Florida, United States
- University of Kansas Cancer Center — Westwood, Kansas, United States
- UofL Health Brown Cancer Center — Louisville, Kentucky, United States
- Nebraska Cancer Specialists — Omaha, Nebraska, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Medical University of South Carolina (MUSC) - Hollings Cancer Center — Charleston, South Carolina, United States
- Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
- SCRI Oncology Partners — Nashville, Tennessee, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
- Centro de Diagnostico Urologico S.R.L. — Buenos Aires, Argentina
- Hospital Britanico de Buenos Aires — Buenos Aires, Argentina
- Hospital Sirio Libanes de Buenos Aires — Buenos Aires, Argentina
- Instituto Alexander Fleming — Buenos Aires, Argentina
- Fundacion Medica Rio Negro y Neuquen — Cipolletti, Argentina
- Centro Medico Privado (CEMAIC) — Córdoba, Argentina
- Fundación CORI para la investigación y Prevención del Cancer — La Rioja, Argentina
- Centro De Investigacion Pergamino S.A. — Pergamino, Argentina
- Instituto de Oncologia de Rosario — Santa Fe, Argentina
- Clinica Viedma S.A. — Viedma, Argentina
- Cancer Research SA — Adelaide, Australia
- Mater Misericordiae Ltd, South Brisbane — Brisbane, Australia
- Rocky Mountain Cancer Center — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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