Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer (NCT06840483)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (11 items).
Location: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC) — Baltimore, Maryland
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (18 Sites)
- 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,
- Oncopole Claudius Regaud — Toulouse,
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRCCS IRST — Meldola, Forli/Cesena
- Clinica Oncologica-Azienda Ospedaliero Universitaria delle Marche — Ancona,
- Istituto Europeo di Oncologia — Milan,
- Hospital Quironsalud Barcelona — Barcelona,
- Hospital Beata Maria Ana — Madrid,
- Hospital Universitario 12 de Octubre — Madrid,
- The Royal Marsden NHS Foundation Trust — London,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.