Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer

BicycleTx

Status and phase

Enrolling

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Zelenectide pevedotin (BT8009)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06840483

BT8009-201 (Duravelo-3)

2024-517868-33-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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).

Enrollment

66 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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