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New drug cocktail targets Hard-to-Treat cancers

NCT ID NCT06618287

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 15, 2026 · Updated 9 times

Summary

This study tests a new drug called BMS-986507, alone or with other cancer medicines, in adults with advanced lung or breast cancer that has spread. The goal is to check safety, side effects, and how well the drugs work. About 416 participants will receive different combinations to find the best dose.

What this could mean

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

Active substance
BMS-986507 (also called Iza-bren or Izalontamab brengitecan) combined with other drugs like osimertinib, pembrolizumab, nivolumab, or pumitamig
What this could lead to
If successful, this could point toward new treatment options for people with advanced lung or breast cancer that has not responded to other therapies.
What could go wrong
This is an early-phase trial (phase 1/2a) with a small number of participants, so the main goal is safety, not proof of effectiveness. The combinations may cause side effects or fail to shrink tumors.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 416 people

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

Started

Feb 2025

Expected to finish

Feb 2031

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 * Participants must have at least one measurable lesion per response evaluation criteria in solid tumors. * Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Participants must have a life expectancy of at least 3 months at the time of the first dose. * Group A: Participants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, which may include T790M in exon 20. Participants with other EGFR mutations (including but not limited to, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations, etc.) will also be allowed * Group B: Participants must have pathologically confirmed locally advanced or metastatic NSCLC. * Group C: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC or ER-low, HER2-negative BC. * Group D: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC per ASCO/CAP criteria, based on the most recently analyzed biopsy or another pathology specimen. * Group E: Participants must have pathologically confirmed locally advanced or metastatic NSCLC, not amenable to treatment in curative intent. Exclusion Criteria * Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology. * Participants with known mutations in EGFR will be excluded (Group A,B and E). * Participants must not have a history of serious recurrent infections. * Participants must not have a history of severe heart disease. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm lung cancer lung neoplasm non-small cell lung carcinoma triple-negative breast carcinoma

As listed by the trial registrant

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

Breast cancer Lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    57 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    RECRUITING

    Marseille, Bouches-du-Rhône, 13385, France

  • Azienda Ospedaliera Universitaria Careggi

    RECRUITING

    Florence, Tuscany, 50134, Italy

  • Bradfordhill

    RECRUITING

    Santiago, Santiago Metropolitan, 8420383, Chile

  • CHUS - Hospital Clinico Universitario

    RECRUITING

    Santiago de Compostela, A Coruña [La Coruña], 15706, Spain

  • Centre Hospitalier de l'Université de Montréal

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • Centre Leon Berard

    RECRUITING

    Lyon, Auvergne-Rhône-Alpes, 69008, France

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cro-Irccs

    RECRUITING

    Aviano, Friuli Venezia Giulia, 33081, Italy

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • FALP

    RECRUITING

    Santiago, Santiago Metropolitan, 7500921, Chile

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    RECRUITING

    Roma, 00168, Italy

  • Gustave Roussy

    RECRUITING

    Villejuif, Val-de-Marne, 94800, France

  • H.R.U Málaga - Hospital General

    RECRUITING

    Málaga, 29011, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    RECRUITING

    Majadahonda, Madrid, Comunidad de, 28222, Spain

  • Hôpital Arnaud de Villeneuve - CHU Montpellier

    RECRUITING

    Montpellier, Hérault, 34090, France

  • Hôpital Tenon

    RECRUITING

    Paris, 75970, France

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    RECRUITING

    Bordeaux, Aquitaine, 33076, France

  • Institut Català d'Oncologia - L'Hospitalet

    RECRUITING

    Hospitalet, Barcelona [Barcelona], 08907, Spain

  • Institut Curie

    RECRUITING

    Paris, 75248, France

  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

    RECRUITING

    Candiolo, Torino, 10060, Italy

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • John Theurer Cancer Center at Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Leids Universitair Medisch Centrum

    RECRUITING

    Leiden, South Holland, 2333 ZA, Netherlands

  • Liverpool Hospital

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • Local Institution - 0001

    NOT_YET_RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Local Institution - 0014

    WITHDRAWN

    Pittsburgh, Pennsylvania, 15232, United States

  • Local Institution - 0021

    NOT_YET_RECRUITING

    Glasgow, Glasgow City, G12 0YN, United Kingdom

  • Local Institution - 0023

    WITHDRAWN

    Ottawa, Ontario, K1H 8L6, Canada

  • Local Institution - 0052

    NOT_YET_RECRUITING

    Portland, Oregon, 97239, United States

  • Local Institution - 0059

    WITHDRAWN

    Barcelona, Catalunya [Cataluña], 08036, Spain

  • Local Institution - 0064

    NOT_YET_RECRUITING

    Newmarket, Ontario, L3Y 2P9, Canada

  • Local Institution - 0065

    NOT_YET_RECRUITING

    Iowa City, Iowa, 52242, United States

  • Local Institution - 0076

    WITHDRAWN

    Caen, Calvados, 14076, France

  • Local Institution - 0077

    WITHDRAWN

    Nice, Alpes-Maritimes, 06189, France

  • Local Institution - 0101

    NOT_YET_RECRUITING

    Subiaco, Western Australia, 6008, Australia

  • Local Institution - 0102

    NOT_YET_RECRUITING

    Columbus, Ohio, 43212, United States

  • Local Institution - 0112

    WITHDRAWN

    Seville, 41009, Spain

  • Local Institution - 0118

    WITHDRAWN

    Valencia, Valenciana, Comunitat, 46010, Spain

  • Local Institution - 0127

    WITHDRAWN

    Madrid, 28040, Spain

  • Local Institution - 0140

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

  • Local Institution - 0144

    NOT_YET_RECRUITING

    Montreal, Quebec, H4A3J1, Canada

  • Local Institution - 0145

    NOT_YET_RECRUITING

    Taipei, 100225, Taiwan

  • Local Institution - 0147

    NOT_YET_RECRUITING

    Tainan, 70428, Taiwan

  • NEXT Oncology - Irving

    RECRUITING

    Irving, Texas, 75039, United States

  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)

    RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • Oncocentro Apys

    RECRUITING

    Viña del Mar, Valparaiso, 2520598, Chile

  • Oncocentro Valdivia

    RECRUITING

    Valdivia, Los Ríos Region, 5112129, Chile

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Pontificia Universidad Catolica de Chile

    RECRUITING

    Santiago, Santiago Metropolitan, 8330032, Chile

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Providence Portland Medical Center

    RECRUITING

    Portland, Oregon, 97213, United States

  • Providence St. Vincent Medical Center

    RECRUITING

    Portland, Oregon, 97225, United States

  • Royal Free Hospital

    RECRUITING

    London, England, NW32QG, United Kingdom

  • Swedish Medical Center

    RECRUITING

    Seattle, Washington, 98104, United States

  • The Ottawa Hospital - General Campus

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • University Hospitals Birmingham NHS Foundation Trust

    RECRUITING

    Birmingham, West Midlands, B15 2GW, United Kingdom

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Miami Hospital and Clinics, Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Tennessee Medical Center

    RECRUITING

    Knoxville, Tennessee, 37920, United States

More trials for these conditions

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