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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06840483
Registration number
NCT06840483
Ethics application status
Date submitted
18/02/2025
Date registered
21/02/2025
Date last updated
16/09/2025
Titles & IDs
Public title
Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer
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Scientific title
Phase 2 Study of Zelenectide Pevedotin in Participants With NECTIN4 Amplified Advanced Breast Cancer
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Secondary ID [1]
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2024-517868-33-00
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Secondary ID [2]
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BT8009-201 (Duravelo-3)
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Zelenectide pevedotin (BT8009)
Experimental: Cohort A (HR+/HER2-negative breast cancer) -
Experimental: Cohort B (TNBC) -
Treatment: Drugs: Zelenectide pevedotin (BT8009)
Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors per RECIST version 1.1 as assessed by the Investigator
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Assessment method [1]
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Percentage of participants with either a confirmed complete response (CR) or partial response (PR)
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Timepoint [1]
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Up to approximately 3 years
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Secondary outcome [1]
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Number of participants reporting adverse events (AEs) and Serious adverse events (SAEs)
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Assessment method [1]
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Safety and tolerability will be reported as incidence, severity, seriousness, relationship, and type of treatment-emergent adverse events, abnormalities in laboratory, electrocardiogram (ECG), vital signs and treatment modifications using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 criteria.
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Timepoint [1]
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Up to approximately 3 years
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Secondary outcome [2]
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Duration of Response (DOR) per RECIST v1.1 as assessed by the Investigator
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Assessment method [2]
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DoR as measured by the time from first documentation of objective response to the first documentation of disease progression assessed by the Investigator or to death (due to any cause), whichever occurs first.
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Timepoint [2]
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Up to approximately 3 years
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Secondary outcome [3]
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Disease Control Rate (DCR) per RECIST v1.1 as assessed by the Investigator
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Assessment method [3]
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Percentage of participants with confirmed CR, PR, or stable disease (SD)
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Timepoint [3]
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Up to approximately 3 years
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Secondary outcome [4]
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Clinical Benefit Rate (CBR) per RECIST v1.1 as assessed by the Investigator
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Assessment method [4]
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Percentage of participants with CR, PR or SD =16 weeks
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Timepoint [4]
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Up to approximately 3 years
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Secondary outcome [5]
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Progression Free Survival (PFS) per RECIST v1.1 as assessed by the Investigator
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Assessment method [5]
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PFS is measured by the time from the first day of study drug administration (Day 1) to the first documentation of disease progression per RECIST v1.1 as assessed by the Investigator, or to death (due to any cause), whichever occurs first.
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Timepoint [5]
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Up to approximately 3 years
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Secondary outcome [6]
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Overall Survival
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Assessment method [6]
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OS is defined as length of time from the first day of study drug administration (Day 1) to death (due to any cause).
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Timepoint [6]
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Up to approximately 4 years
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Secondary outcome [7]
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Time To Progression (TTP) per RECIST v1.1 as assessed by the Investigator
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Assessment method [7]
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TTP is defined as the time from first dose of study drug administration until first documentation of disease progression.
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Timepoint [7]
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Up to approximately 4 years
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Eligibility
Key inclusion 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 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 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/03/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/12/2028
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Actual
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Sample size
Target
66
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment outside Australia
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United States of America
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Colorado
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United States of America
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Connecticut
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Massachusetts
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United States of America
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Michigan
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Missouri
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New York
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North Carolina
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Oregon
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United States of America
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Tennessee
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Texas
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Virginia
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United States of America
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Washington
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France
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Lyon
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France
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Rennes
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France
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Toulouse
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Italy
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Forli/Cesena
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Italy
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Ancona
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Italy
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Milan
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Spain
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Barcelona
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Spain
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Madrid
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United Kingdom
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London
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BicycleTx Limited
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT06840483
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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BicycleTx Limited
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Address
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Phone
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617-945-8155
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06840483
Download to PDF