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NCT06840483 · ClinicalTrials.gov registry record · Phase 2
Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by BicycleTx Limited.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 20
- Study locations
NCT06840483: Recruiting Phase 2 study of Breast Cancer, sponsored by BicycleTx Limited.
NCT06840483 is a Phase 2 study of Breast Cancer that is actively recruiting participants, run by BicycleTx Limited. The registered enrollment target is 66 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06840483, a Phase 2 study of Breast Cancer, is actively recruiting participants, sponsored by BicycleTx Limited.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Percentage of participants with either a confirmed complete response (CR) or partial response (PR)
Conditions Studied
Interventions
- DRUG Zelenectide pevedotin (BT8009)
Study Locations (20)
Texas
- University of Texas Southwestern Medical Center - Dallas
- O'Quinn Medical Tower - McNair Campus (Baylor College of Medicine Medical Center) - Houston
- Texas Oncology San Antonio - San Antonio
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
New York
- Icahn School of Medicine at Mount Sinai - New York
- Memorial Sloan Kettering Cancer Center - Main Campus - New York
Virginia
- Virginia Cancer Specialists - Fairfax
- Virginia Oncology Associates - Norfolk
California
- City of Hope National Medical Center - Duarte
Colorado
- University of Colorado Denver - Aurora
Connecticut
- Yale New Haven Hospital - Yale Cancer Center - New Haven
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2025-03-03 |
| Est. Completion | 2028-12-30 |
| Phase | Phase 2 |
What NCT06840483 shows while recruiting
NCT06840483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Zelenectide pevedotin (BT8009) is the first listed.
NCT06840483 names 20 study sites across 15 states, led by Texas, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT06840483 about?
NCT06840483 is a clinical study titled "Study of Zelenectide Pevedotin in Participants With 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 ...
What is the current status of trial NCT06840483?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2025-03-03. Estimated completion is 2028-12-30.
What conditions does trial NCT06840483 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT06840483?
The interventions under investigation include: Zelenectide pevedotin (BT8009) (DRUG).
Who is sponsoring clinical trial NCT06840483?
This trial is sponsored by BicycleTx Limited, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06840483 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06840483's enrollment target sits among peer trials
66 718th of 1224 higher than 504 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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