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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 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.

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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).

Conditions Studied

Breast Cancer

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, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is BicycleTx Limited, which has 7 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.