OncoMatch/Clinical Trials/NCT06840483
Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer
Is NCT06840483 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Zelenectide pevedotin (BT8009) for breast cancer.
Treatment: Zelenectide pevedotin (BT8009) — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: NECTIN4 gene amplification
Confirmed NECTIN4 gene amplification by an analytically validated clinical trial assay (CTA).
Excluded: HER2 (ERBB2) overexpression
Previously tested HER2-positive (IHC 3+ or ISH+) on prior pathology testing (per ASCO-CAP guidelines).
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: non-endocrine-based therapy — advanced disease
received at least 1 and up to 3 prior lines of non-endocrine-based therapy for advanced disease
Must have received: systemic therapy — advanced disease
have received at least 1 and up to 3 prior lines of systemic therapy for advanced disease
Cannot have received: antibody-drug conjugate containing MMAE
Prior treatment with any antibody drug conjugate (ADC) containing an Monomethyl Auristatin E (MMAE) (vedotin) payload or other MMAE-based therapy.
Cannot have received: systemic anticancer therapy
Exception: within 28 days or 5 half-lives, whichever is shorter, prior to first dose
Prior treatment with any systemic anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to first dose of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope National Medical Center · Duarte, California
- University of Colorado Denver · Aurora, Colorado
- Yale New Haven Hospital - Yale Cancer Center · New Haven, Connecticut
- Sibley Memorial Hospital · Washington D.C., District of Columbia
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC) · Baltimore, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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