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NCT06225596 · ClinicalTrials.gov registry record · Phase 2
Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
A Phase 2 study of Metastatic Urothelial Cancer, sponsored by BicycleTx Limited.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 956
- Enrollment target
- 20
- Study locations
NCT06225596: Recruiting Phase 2 study of Metastatic Urothelial Cancer, sponsored by BicycleTx Limited.
NCT06225596 is a Phase 2 study of Metastatic Urothelial Cancer that is actively recruiting participants, run by BicycleTx Limited. The registered enrollment target is 956 participants, above the 461-participant average among 5 other Metastatic Urothelial Cancer trials with a reported enrollment target (107% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06225596, a Phase 2 study of Metastatic Urothelial Cancer, is actively recruiting participants, sponsored by BicycleTx Limited.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 956 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The time from randomization to date of first documentation of disease progression or death.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG BT8009
- DRUG Gemcitabine + cisplatin Or carboplatin
Study Locations (20)
Florida
- Cancer Specialists of North Florida - Jacksonville
- University of Miami - Sylvester Comprehensive Cancer Center - Miami
- AP Medical Research - Miami
- Mount Sinai Medical Center of Florida, Inc. - Miami Beach
- Moffitt - Tampa
California
- Virginia K. Crosson Cancer Center at St. Jude Medical Center - Fullerton
- University of California - Irvine Medical Center - Orange
- University of California, San Francisco (UCSF) - San Francisco
- Adventist Health St. Helena - St. Helena
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Colorado
- Rocky Mountain Cancer Center - Denver
Connecticut
- Yale University School of Medicine - Yale Cancer Center - New Haven
Delaware
- Medical Oncology Hematology Consultants - Newark
Illinois
- Southern Illinois University (SIU) - Simmons Cancer Institute - Springfield
Iowa
- Mission Cancer + Blood - Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 956 participants |
| Start Date | 2024-01-24 |
| Est. Completion | 2030-12 |
| Phase | Phase 2 |
What NCT06225596 shows while recruiting
NCT06225596 is an interventional study that assigns participants to a tested intervention. The registered 956 participants enrollment target is mid-sized for trials with a published cap, above the 461-participant average among 5 other Metastatic Urothelial Cancer trials with a reported enrollment target (107% higher).
The record links to 1 condition, with Metastatic Urothelial Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT06225596 names 20 study sites across 13 states, led by Florida, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06225596 about?
NCT06225596 is a clinical study titled "Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)". 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 uroth...
What is the current status of trial NCT06225596?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 956 participants. The study started on 2024-01-24. Estimated completion is 2030-12.
What conditions does trial NCT06225596 study?
This clinical trial studies the following conditions: Metastatic Urothelial Cancer.
What interventions are being tested in trial NCT06225596?
The interventions under investigation include: Pembrolizumab (DRUG), BT8009 (DRUG), Gemcitabine + cisplatin Or carboplatin (DRUG).
Who is sponsoring clinical trial NCT06225596?
This trial is sponsored by BicycleTx Limited, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06225596 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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