Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer
Phase 2 Study of Zelenectide Pevedotin in Participants With NECTIN4 Amplified Advanced Breast Cancer
BicycleTx Limited
66 participants
Mar 3, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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.
Exclusion Criteria10
- 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
Interventions
Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
Locations(39)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06840483