NCT06225596

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

A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 956 (estimated)
• Sponsor: BicycleTx Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a global, multicenter, randomized, open-label study, with an adaptive design. The main objective of the study is to measure the efficacy and safety of BT8009 (zelenectide pevedotin) as monotherapy and in combination with pembrolizumab in participants with locally advanced or metastatic urothelial cancer (UC). The study includes a dose selection phase followed by an adaptive design continuation. The study 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.

Conditions

• Metastatic Urothelial Cancer

Interventions

Type	Name	Description
DRUG	BT8009	Participants will receive BT8009 on Days 1, 8, and 15 of every 21-day cycle.
DRUG	BT8009	Participants will receive BT8009 on Days 1 and 8 of every 21-day cycle.
DRUG	BT8009	Participants will receive BT8009 on days 1, 8 +/- 15 schedule of every 21-day cycle.
DRUG	Pembrolizumab	Participants will receive Pembrolizumab on Day 1 of every 21-day cycle. Pembrolizumab infusion will be started 30 minutes following the completion of the BT8009 infusion.
DRUG	Gemcitabine + cisplatin Or carboplatin	Participants will receive Gemcitabine on Days 1 and 8 of every 21-day cycle plus cisplatin Or carboplatin on Day 1 of every 21-day cycle.
DRUG	Avelumab	After 4-6 cycles of Gemcitabine + Cisplatin or Carboplatin participants will receive maintenance Avelumab, if clinically indicated, on Days 1 and 15 each 28-day cycle.

Timeline

• Start date: 2024-01-24
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2024-01-26
• Last updated: 2026-04-15

Locations

104 sites across 21 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, France, Georgia, Germany, Hungary, Israel, Italy, Poland, Serbia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study