Study to Assess Clinical Activity of Zelenectide Pevedotin in Participants With Advanced Breast Cancer
- Study HIC#:2000039480
- Last Updated:09/18/2025
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).
Contact Us
For more information about this study, including how to volunteer, contact:
Carl Brown
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Eligibility Criteria
Inclusion Criteria
- Archival or fresh tumor tissue comprised of recurrent unresectable or metastatic TNBC or HR+/HER2-negative breast cancer available for NECTIN4 gene amplification testing.
- Confirmed NECTIN4 gene amplification by an analytically validated clinical trial assay.
- Measurable disease as defined by RECIST v1.1.
- Life expectancy ≥ 12 weeks.
- Eastern Cooperative Oncology Group Performance Status of ≤ 2.
- Cohort A Specific Inclusion Criteria: Histologically or cytologically confirmed HR+/HER2-negative endocrine resistant/refractory breast cancer according to ASCO-CAP guidelines and received up to 3 prior lines of non-endocrine 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 but no more than 3 prior lines of systemic therapy for advanced disease.
Exclusion Criteria
- Prior treatment with any antibody drug conjugate 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 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 CNS metastases.
- Uncontrolled diabetes or hypertension.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent draining procedures (monthly or more frequently).
- Active interstitial lung disease or penumonitis requiring ongoing treatment with steriods (>10mg/day of prednisone or equivalent) or other immunosupressive medications.
- Requirement, while on study, for treatment with strong inhiitors 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
