Breast CancerPhase 2NCT06840483
Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer
A Phase 2 study testing Zelenectide pevedotin (BT8009) in people with Breast Cancer, run by BicycleTx Limited at 18 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Zelenectide pevedotin (BT8009)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 3 Mar 2025to 30 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
United States8 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC)
Baltimore, Maryland, 21287
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Duke Cancer Institute
Durham, North Carolina, 27710
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
Compass Oncology - Rose Quarter Cancer Center
Portland, Oregon, 97227
Texas Oncology San Antonio
San Antonio, Texas, 78240
Siteman Cancer Center
St Louis, Missouri, 63108
Italy3 sites
Clinica Oncologica-Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRCCS IRST
Meldola, Forli/Cesena, 47014
Istituto Europeo di Oncologia
Milan, 20141
Spain3 sites
Hospital Quironsalud Barcelona
Barcelona, 08023
Hospital Beata Maria Ana
Madrid, 28007
Hospital Universitario 12 de Octubre
Madrid, 28041
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
About this study
Official title: Phase 2 Study of Zelenectide Pevedotin in Participants With NECTIN4 Amplified Advanced Breast Cancer
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
- Being tested
- Zelenectide pevedotin (BT8009)
- Keywords
- NECTIN4, Zelenectide pevedotin, HR+/HER2-negative, TNBC, Chemotherapy, Duravelo-3, Advanced Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zelenectide pevedotin (BT8009)Drug
Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (HR+/HER2-negative breast cancer) | Experimental | Not described Receives: Drug: Zelenectide pevedotin (BT8009) |
| Cohort B (TNBC) | Experimental | Not described Receives: Drug: Zelenectide pevedotin (BT8009) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to approximately 3 years
Secondary outcomes (7)
Number of participants reporting adverse events (AEs) and Serious adverse events (SAEs)
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.
Measured: Up to approximately 3 years
Duration of Response (DOR) per RECIST v1.1 as assessed by the Investigator
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.
Measured: Up to approximately 3 years
Disease Control Rate (DCR) per RECIST v1.1 as assessed by the Investigator
Percentage of participants with confirmed CR, PR, or stable disease (SD)
Measured: Up to approximately 3 years
Clinical Benefit Rate (CBR) per RECIST v1.1 as assessed by the Investigator
Percentage of participants with CR, PR or SD ≥16 weeks
Measured: Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 as assessed by the Investigator
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.
Measured: Up to approximately 3 years
Overall Survival
OS is defined as length of time from the first day of study drug administration (Day 1) to death (due to any cause).
Measured: Up to approximately 4 years
Time To Progression (TTP) per RECIST v1.1 as assessed by the Investigator
TTP is defined as the time from first dose of study drug administration until first documentation of disease progression.
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start3 Mar 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BicycleTx Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840483
- Sponsor's protocol ID
- BT8009-201 (Duravelo-3)
- Other IDs
- 2024-517868-33-00
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Zelenectide Pevedotin in Participants With NECTIN4 Amplified Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06840483
- Acronym / sponsor ID
- BT8009-201 (Duravelo-3)
- Conditions
- Breast Cancer
- Keywords
- NECTIN4, Zelenectide pevedotin, HR+/HER2-negative, TNBC, Chemotherapy, Duravelo-3, Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- BicycleTx LimitedIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (HR+/HER2-negative breast cancer) | Experimental | Drug: Zelenectide pevedotin (BT8009) |
| Cohort B (TNBC) | Experimental | Drug: Zelenectide pevedotin (BT8009) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zelenectide pevedotin (BT8009)Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle. | Drug | Cohort A (HR+/HER2-negative breast cancer), Cohort B (TNBC) |
Primary outcome
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors per RECIST version 1.1 as assessed by the Investigator
Time frame: Up to approximately 3 years
Percentage of participants with either a confirmed complete response (CR) or partial response (PR)
7 secondary outcomes
Number of participants reporting adverse events (AEs) and Serious adverse events (SAEs)
Time frame: Up to approximately 3 years
Duration of Response (DOR) per RECIST v1.1 as assessed by the Investigator
Time frame: Up to approximately 3 years
Disease Control Rate (DCR) per RECIST v1.1 as assessed by the Investigator
Time frame: Up to approximately 3 years
Clinical Benefit Rate (CBR) per RECIST v1.1 as assessed by the Investigator
Time frame: Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 as assessed by the Investigator
Time frame: Up to approximately 3 years
Overall Survival
Time frame: Up to approximately 4 years
Time To Progression (TTP) per RECIST v1.1 as assessed by the Investigator
Time frame: Up to approximately 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zelenectide pevedotin (BT8009) in people with Breast Cancer, run by BicycleTx Limited at 18 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Italy, Spain, Australia, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors per RECIST version 1.1 as assessed by the Investigator (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.