Study to Assess Clinical Activity 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 Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort A (HR+/HER2-negative breast cancer) |
|
|
|
Experimental Cohort B (TNBC) |
|
Recruiting Locations
Siteman Cancer Center
Saint Louis, Missouri 63108
Saint Louis, Missouri 63108
Compass Oncology - Rose Quarter Cancer Center
Portland, Oregon 97227
Portland, Oregon 97227
SCRI Oncology Partners
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Texas Oncology San Antonio
San Antonio, Texas 78240
San Antonio, Texas 78240
Virginia Oncology Associates
Norfolk, Virginia 23502
Norfolk, Virginia 23502
More Details
- NCT ID
- NCT06840483
- Status
- Recruiting
- Sponsor
- BicycleTx Limited