Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer
NCT ID: NCT06840483
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
66 participants
INTERVENTIONAL
2025-03-03
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A (HR+/HER2-negative breast cancer)
Zelenectide pevedotin (BT8009)
Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
Cohort B (TNBC)
Zelenectide pevedotin (BT8009)
Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
Interventions
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Zelenectide pevedotin (BT8009)
Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Known hypersensitivity or allergy to any of the ingredients of any of the study interventions, or to MMAE.
* Previously tested HER2-positive (IHC 3+ or ISH+) on prior pathology testing (per ASCO-CAP guidelines).
* Active keratitis or corneal ulcerations.
* Active or untreated central nervous system (CNS) metastases.
* Uncontrolled diabetes or hypertension.
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
* Active interstitial lung disease or pneumonitis requiring ongoing treatment with steroids (\>10mg/day of prednisone or equivalent) or other immunosuppressive medications.
* Requirement, while on study, for treatment with strong inhibitors or strong inducers of human cytochrome P450 3A (CYP3A) or inhibitors of P-glycoprotein (P-gp) including herbal- or food-based inhibitors.
* Prior treatment with any systemic anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to first dose of study treatment
18 Years
ALL
No
Sponsors
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BicycleTx Limited
INDUSTRY
Responsible Party
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Locations
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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
Napoli, , 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
Countries
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Central Contacts
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Other Identifiers
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2024-517868-33-00
Identifier Type: CTIS
Identifier Source: secondary_id
BT8009-201 (Duravelo-3)
Identifier Type: -
Identifier Source: org_study_id
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