Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer

Purpose

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).

Condition

  • Breast Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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. 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. 2. 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.

Exclusion Criteria

  • Prior treatment with any antibody drug conjugate (ADC) containing an Monomethyl Auristatin E (MMAE) (vedotin) payload or other MMAE-based therapy. - 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 Note: Additional protocol defined Inclusion/Exclusion criteria apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort A (HR+/HER2-negative breast cancer)
  • Drug: Zelenectide pevedotin (BT8009)
    Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
Experimental
Cohort B (TNBC)
  • Drug: Zelenectide pevedotin (BT8009)
    Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.

Recruiting Locations

City of Hope National Medical Center
Duarte 5344147, California 5332921 91010

University of Colorado Denver
Aurora 5412347, Colorado 5417618 80045

Yale New Haven Hospital - Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06510

Sibley Memorial Hospital
Washington D.C. 4140963, District of Columbia 4138106 20016

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC)
Baltimore 4347778, Maryland 4361885 21287

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109

Siteman Cancer Center
St Louis 4407066, Missouri 4398678 63108

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029

Memorial Sloan Kettering Cancer Center - Main Campus
New York 5128581, New York 5128638 10065

Duke Cancer Institute
Durham 4464368, North Carolina 4482348 27710

Compass Oncology - Rose Quarter Cancer Center
Portland 5746545, Oregon 5744337 97227

SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203

University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390

O'Quinn Medical Tower - McNair Campus (Baylor College of Medicine Medical Center)
Houston 4699066, Texas 4736286 77054

Texas Oncology San Antonio
San Antonio 4726206, Texas 4736286 78240

University of Vermont Medical Center
Burlington 5234372, Vermont 5242283 05401

Virginia Cancer Specialists
Fairfax 4758023, Virginia 6254928 22031

Virginia Oncology Associates
Norfolk 4776222, Virginia 6254928 23502

Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109

More Details

NCT ID
NCT06840483
Status
Recruiting
Sponsor
BicycleTx Limited

Study Contact

BicycleTx Limited
617-945-8155
clinicalstudies@bicycletx.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center