Zelenectide pevedotin (BT8009): Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors per RECIST version 1.1 as assessed by the Investigator — Up to approximately 3 years Percentage of participants with either a confirmed complete response (CR) or partial response (PR)
Trial sites (18)
Facility
City
Region
Status
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC)
Baltimore
Maryland
Dana-Farber Cancer Institute
Boston
Massachusetts
Siteman Cancer Center
St Louis
Missouri
Memorial Sloan Kettering Cancer Center - Main Campus
New York
New York
Duke Cancer Institute
Durham
North Carolina
Compass Oncology - Rose Quarter Cancer Center
Portland
Oregon
Texas Oncology San Antonio
San Antonio
Texas
Virginia Cancer Specialists
Fairfax
Virginia
Peter MacCallum Cancer Centre
Melbourne
Victoria
UZ Leuven
Leuven
Belgium
Oncopole Claudius Regaud
Toulouse
France
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRCCS IRST
Meldola
Forli/Cesena
Clinica Oncologica-Azienda Ospedaliero Universitaria delle Marche
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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