Phase 2 Study of Zelenectide Pevedotin in Participants With NECTIN4 Amplified Advanced Breast Cancer
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Archival or fresh tumor tissue comprised of TNBC or HR+/HER2-negative invasive breast cancer available for NECTIN4 gene amplification testing.
• Confirmed NECTIN4 gene amplification by an analytically validated clinical trial assay (CTA).
• Measurable disease as defined by RECIST v1.1.
• Life expectancy ≥ 12 weeks.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤ 1.
‣ Cohort A Specific Inclusion Criteria: Histologically or cytologically confirmed HR+/HER2-negative endocrine resistant/refractory breast cancer according to ASCO-CAP guidelines and received at least 1 and up to 3 prior lines of non-endocrine-based therapy for advanced disease.
⁃ Cohort B Specific Inclusion Criteria: Histologically or cytologically confirmed TNBC, including ER-low positive breast cancers (1-10% of cells expressing hormonal receptors by IHC), according to ASCO-CAP guidelines and have received at least 1 and up to 3 prior lines of systemic therapy for advanced disease.
Locations
United States
Colorado
University of Colorado Denver
RECRUITING
Aurora
Connecticut
Yale New Haven Hospital - Yale Cancer Center
RECRUITING
New Haven
Washington, D.c.
Sibley Memorial Hospital
RECRUITING
Washington D.c.
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC)
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
Missouri
Siteman Cancer Center
RECRUITING
St Louis
North Carolina
Duke Cancer Institute
RECRUITING
Durham
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Memorial Sloan Kettering Cancer Center - Main Campus
RECRUITING
New York
Oregon
Compass Oncology - Rose Quarter Cancer Center
RECRUITING
Portland
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Texas Oncology San Antonio
RECRUITING
San Antonio
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Virginia Oncology Associates
RECRUITING
Norfolk
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Other Locations
Australia
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
France
Centre Leon Berard
RECRUITING
Lyon
Centre de Lutte Contre le Cancer - Centre Eugene Marquis
RECRUITING
Rennes
Oncopole Claudius Regaud
RECRUITING
Toulouse
Italy
Clinica Oncologica-Azienda Ospedaliero Universitaria delle Marche
RECRUITING
Ancona
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRCCS IRST
RECRUITING
Meldola
Istituto Europeo di Oncologia
RECRUITING
Milan
Spain
Hospital Quironsalud Barcelona
RECRUITING
Barcelona
Centro Integral Oncologico Clara Campal
RECRUITING
Madrid
Hospital Beata Maria Ana
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
United Kingdom
Barts Health NHS Trust
RECRUITING
London
The Royal Marsden NHS Foundation Trust
RECRUITING
London
The Royal Marsden NHS Foundation Trust
RECRUITING
Sutton
Contact Information
Primary
BicycleTx Limited
clinicalstudies@bicycletx.com
617-945-8155
Time Frame
Start Date:2025-03-03
Estimated Completion Date:2028-12-30
Participants
Target number of participants:66
Treatments
Experimental: Cohort A (HR+/HER2-negative breast cancer)