Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug targets Gene-Mutated breast cancer in phase 2 trial

NCT ID NCT06840483

Disease control Sponsor: BicycleTx Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 study tests a drug called zelenectide pevedotin in 66 people with advanced breast cancer that has a specific gene change (NECTIN4 amplification). The study includes two groups: one with hormone receptor-positive/HER2-negative cancer and one with triple-negative breast cancer. The main goal is to see if the drug shrinks tumors, while also checking for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zelenectide pevedotin (BT8009)
What this could lead to
If successful, this could provide a new treatment option for people with advanced breast cancer that has a specific genetic marker (NECTIN4 amplification).
What could go wrong
This is an early Phase 2 study with only 66 participants, so results may not apply to everyone. The drug may cause side effects or not shrink tumors as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. 2. 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. 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Clinica Oncologica-Azienda Ospedaliero Universitaria delle Marche

    Ancona, 60126, Italy

  • Compass Oncology - Rose Quarter Cancer Center

    Portland, Oregon, 97227, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Institute

    Durham, North Carolina, 27710, United States

  • Hospital Beata Maria Ana

    Madrid, 28007, Spain

  • Hospital Quironsalud Barcelona

    Barcelona, 08023, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRCCS IRST

    Meldola, Forli/Cesena, 47014, Italy

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York, 10065, United States

  • Oncopole Claudius Regaud

    Toulouse, 31059, France

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC)

    Baltimore, Maryland, 21287, United States

  • Siteman Cancer Center

    St Louis, Missouri, 63108, United States

  • Texas Oncology San Antonio

    San Antonio, Texas, 78240, United States

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ, United Kingdom

  • UZ Leuven

    Leuven, 3000, Belgium

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.