Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer

Running, not enrolling · Phase 2

Conditions studied: Breast Cancer

In brief

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).

Key facts

Study ID

NCT06840483

Run by

BicycleTx Limited

People needed

66

Starts

2025-03-03

Expected to finish

2028-12-30

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• 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.

You may not qualify if…

• 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

Where it is running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC) — Baltimore, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Siteman Cancer Center — St Louis, Missouri, United States
• Memorial Sloan Kettering Cancer Center - Main Campus — New York, New York, United States
• Duke Cancer Institute — Durham, North Carolina, United States
• Compass Oncology - Rose Quarter Cancer Center — Portland, Oregon, United States
• Texas Oncology San Antonio — San Antonio, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
• UZ Leuven — Leuven, Belgium
• Oncopole Claudius Regaud — Toulouse, France
• Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRCCS IRST — Meldola, Forli/Cesena, Italy
• Clinica Oncologica-Azienda Ospedaliero Universitaria delle Marche — Ancona, Italy
• Istituto Europeo di Oncologia — Milan, Italy
• Hospital Quironsalud Barcelona — Barcelona, Spain
• Hospital Beata Maria Ana — Madrid, Spain
• Hospital Universitario 12 de Octubre — Madrid, Spain
• The Royal Marsden NHS Foundation Trust — London, United Kingdom

Full record on ClinicalTrials.gov

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