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Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer
Sponsor: BicycleTx Limited
Summary
This is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with NECTIN4-amplified recurrent, unresectable, or metastatic breast cancer who have received prior therapy (see inclusion criteria below). The study will comprise of 2 cohorts. Cohort A will include participants with hormone receptor positive/ human epidermal growth factor receptor 2 negative \[HR+/HER2-\] breast cancer, whereas Cohort B will include participants with triple-negative breast cancer (TNBC).
Official title: Phase 2 Study of Zelenectide Pevedotin in Participants With NECTIN4 Amplified Advanced Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2025-03-03
Completion Date
2028-12-30
Last Updated
2026-01-13
Healthy Volunteers
No
Conditions
Interventions
Zelenectide pevedotin (BT8009)
Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
Locations (39)
City of Hope National Medical Center
Duarte, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Yale New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC)
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Siteman Cancer Center
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Compass Oncology - Rose Quarter Cancer Center
Portland, Oregon, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
O'Quinn Medical Tower - McNair Campus (Baylor College of Medicine Medical Center)
Houston, Texas, United States
Texas Oncology San Antonio
San Antonio, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Institut Jules Bordet
Brussels, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Centre Leon Berard
Lyon, France
Centre de Lutte Contre le Cancer - Centre Eugene Marquis
Rennes, France
Oncopole Claudius Regaud
Toulouse, France
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRCCS IRST
Meldola, Forli/Cesena, Italy
Clinica Oncologica-Azienda Ospedaliero Universitaria delle Marche
Ancona, Italy
Istituto Europeo di Oncologia
Milan, Italy
S.C. Oncologia Clinica Sperimentale di Senologia - IRCCS Fondazione Pascale
Naples, Italy
Hospital Quironsalud Barcelona
Barcelona, Spain
Hospital Beata Maria Ana
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Centro Integral Oncologico Clara Campal
Madrid, Spain
Barts Health NHS Trust
London, United Kingdom
The Royal Marsden NHS Foundation Trust
London, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom