Clinical Trials Logo
  1. Home
  2. Metastatic Urothelial Cancer
  3. NCT06225596

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

Metastatic Urothelial Cancer Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06225596
Study type Interventional
Source BicycleTx Limited
Contact BicycleTx Limited
Phone 617-945-8155
Email clinicalstudies@bicycletx.com
Status Recruiting
Phase Phase 2/Phase 3
Start date January 24, 2024
Completion date December 2030
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03682068 - Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer Phase 3
Recruiting NCT05101096 - Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors Phase 1/Phase 2
Completed NCT02826564 - Trial of Stereotactic Body Radiotherapy With Concurrent Pembrolizumab in Metastatic Urothelial Cancer Phase 1
Completed NCT01963052 - ASG-15ME is a Study of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer Phase 1
Not yet recruiting NCT05390645 - A Study of MFA-370 in Patients With Metastatic Urothelial Cancer Phase 1/Phase 2
Recruiting NCT03745911 - Paclitaxel and TAK-228 in Urothelial Carcinoma Phase 2
Completed NCT03390595 - Avelumab Plus Carboplatin-gemcitabine in Urothelial Carcinoma Phase 2
Completed NCT03451331 - Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic Urothelial Cancer Phase 2
Active, not recruiting NCT04995419 - A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy Phase 2
Completed NCT03679767 - A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203) Phase 2
Completed NCT02240017 - A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function. Phase 2/Phase 3
Recruiting NCT03547973 - Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread Phase 2
Completed NCT03070990 - A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma Phase 1
Completed NCT03448718 - Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations Phase 2