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RECRUITING Phase 2

Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer

NCT06840483 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 66 participants
Start Date 2025-03-03
Est. Completion 2028-12-30
Phase Phase 2

Sponsor

BicycleTx Limited

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06840483

The ClinicalTrials.gov registry entry for NCT06840483 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BicycleTx Limited, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06840483 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Texas, Massachusetts, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06840483?

The interventions under investigation include: Zelenectide pevedotin (BT8009) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06840483?

This trial is sponsored by BicycleTx Limited, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial