Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer

NCT06840483 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: BT8009-201 (Duravelo-3)2024-517868-33-00
• Study Type: interventional
• Target: 66
• Locations: 7 countries
• Sites: 18

Brief 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).

Conditions

Breast Cancer

Keywords

NECTIN4; Zelenectide pevedotin; HR+/HER2-negative; TNBC; Chemotherapy; Duravelo-3; Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors per RECIST version 1.1 as assessed by the Investigator

  Percentage of participants with either a confirmed complete response (CR) or partial response (PR)

  Up to approximately 3 years

Secondary Outcomes (7)

• Number of participants reporting adverse events (AEs) and Serious adverse events (SAEs)

  Up to approximately 3 years

• Duration of Response (DOR) per RECIST v1.1 as assessed by the Investigator

  Up to approximately 3 years

• Disease Control Rate (DCR) per RECIST v1.1 as assessed by the Investigator

  Up to approximately 3 years

• Clinical Benefit Rate (CBR) per RECIST v1.1 as assessed by the Investigator

  Up to approximately 3 years

• Progression Free Survival (PFS) per RECIST v1.1 as assessed by the Investigator

  Up to approximately 3 years

Study Arms (2)

Cohort A (HR+/HER2-negative breast cancer)

EXPERIMENTAL

Drug: Zelenectide pevedotin (BT8009)

Cohort B (TNBC)

EXPERIMENTAL

Drug: Zelenectide pevedotin (BT8009)

Interventions

Zelenectide pevedotin (BT8009) DRUG

Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.

Cohort A (HR+/HER2-negative breast cancer); Cohort B (TNBC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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

Sponsors & Collaborators

• BicycleTx Limited: lead

Study Sites (18)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC)

Baltimore, Maryland, 21287, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63108, United States

Location

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, 10065, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Compass Oncology - Rose Quarter Cancer Center

Portland, Oregon, 97227, United States

Location

Texas Oncology San Antonio

San Antonio, Texas, 78240, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Oncopole Claudius Regaud

Toulouse, 31059, France

Location

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRCCS IRST

Meldola, Forli/Cesena, 47014, Italy

Location

Clinica Oncologica-Azienda Ospedaliero Universitaria delle Marche

Ancona, 60126, Italy

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Hospital Quironsalud Barcelona

Barcelona, 08023, Spain

Location

Hospital Beata Maria Ana

Madrid, 28007, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 21, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); ES (3); AU (1); US (8); IT (3); GB (1); BE (1)