A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

NCT ID: NCT06618287

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-04

Study Completion Date

2031-02-26

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.

Detailed Description

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Conditions

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Lung Cancer Breast Cancer

Keywords

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Non-Small Cell Lung Cancer (NSCLC) Epidermal Growth Factor Receptor mutated (EGFRmt) Epidermal Growth Factor Receptor wild-type (EGFRwt) Triple-negative breast cancer (TNBC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Group Type EXPERIMENTAL

BMS-986507

Intervention Type DRUG

Specified dose on specified days

Osimertinib

Intervention Type DRUG

Specified dose on specified days

Group B

Group Type EXPERIMENTAL

BMS-986507

Intervention Type DRUG

Specified dose on specified days

Pembrolizumab

Intervention Type DRUG

Specified dose on specified days

Group C

Group Type EXPERIMENTAL

BMS-986507

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Group D

Group Type EXPERIMENTAL

BMS-986507

Intervention Type DRUG

Specified dose on specified days

Pumitamig

Intervention Type DRUG

Specified dose on specified days

Group E

Group Type EXPERIMENTAL

BMS-986507

Intervention Type DRUG

Specified dose on specified days

Pumitamig

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986507

Specified dose on specified days

Intervention Type DRUG

Osimertinib

Specified dose on specified days

Intervention Type DRUG

Pembrolizumab

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type DRUG

Pumitamig

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Iza-bren Izalontamab brengitecan Opdivo BMS-936558 BMS-986545 BNT327 PM8002

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0066

Birmingham, Alabama, United States

Site Status NOT_YET_RECRUITING

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, United States

Site Status RECRUITING

Local Institution - 0065

Iowa City, Iowa, United States

Site Status NOT_YET_RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

Local Institution - 0102

Columbus, Ohio, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0052

Portland, Oregon, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0090

Portland, Oregon, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0014

Pittsburgh, Pennsylvania, United States

Site Status WITHDRAWN

Local Institution - 0103

Knoxville, Tennessee, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0092

Irving, Texas, United States

Site Status NOT_YET_RECRUITING

Swedish Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Liverpool Hospital

Liverpool, New South Wales, Australia

Site Status RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status RECRUITING

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status RECRUITING

Local Institution - 0064

Newmarket, Ontario, Canada

Site Status NOT_YET_RECRUITING

Local Institution - 0023

Ottawa, Ontario, Canada

Site Status WITHDRAWN

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Site Status RECRUITING

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Local Institution - 0048

Santiago, Santiago Metropolitan, Chile

Site Status NOT_YET_RECRUITING

Local Institution - 0049

Santiago, Santiago Metropolitan, Chile

Site Status NOT_YET_RECRUITING

Local Institution - 0047

Santiago, Santiago Metropolitan, Chile

Site Status NOT_YET_RECRUITING

Local Institution - 0077

Nice, Alpes-Maritimes, France

Site Status NOT_YET_RECRUITING

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

Bordeaux, Aquitaine, France

Site Status RECRUITING

Local Institution - 0050

Lyon, Auvergne-Rhône-Alpes, France

Site Status NOT_YET_RECRUITING

Local Institution - 0045

Marseille, Bouches-du-Rhône, France

Site Status NOT_YET_RECRUITING

Hôpital Arnaud de Villeneuve - CHU Montpellier

Montpellier, Hérault, France

Site Status RECRUITING

Local Institution - 0041

Villejuif, Val-de-Marne, France

Site Status NOT_YET_RECRUITING

Local Institution - 0076

Caen, , France

Site Status NOT_YET_RECRUITING

Local Institution - 0054

Paris, , France

Site Status NOT_YET_RECRUITING

Hôpital Tenon

Paris, , France

Site Status RECRUITING

Cro-Irccs

Aviano, Friuli Venezia Giulia, Italy

Site Status RECRUITING

Local Institution - 0033

Milan, Lombardy, Italy

Site Status NOT_YET_RECRUITING

Local Institution - 0056

Candiolo, Torino, Italy

Site Status NOT_YET_RECRUITING

Local Institution - 0035

Florence, Tuscany, Italy

Site Status NOT_YET_RECRUITING

Local Institution - 0093

Milan, , Italy

Site Status NOT_YET_RECRUITING

Local Institution - 0032

Roma, , Italy

Site Status NOT_YET_RECRUITING

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Site Status RECRUITING

Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)

Amsterdam, , Netherlands

Site Status RECRUITING

Local Institution - 0062

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

Site Status NOT_YET_RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Site Status RECRUITING

Local Institution - 0058

Hospitalet, Barcelona [Barcelona], Spain

Site Status NOT_YET_RECRUITING

Local Institution - 0059

Barcelona, Catalunya [Cataluña], Spain

Site Status WITHDRAWN

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, Spain

Site Status RECRUITING

Local Institution - 0061

Majadahonda, Madrid, Comunidad de, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, , Spain

Site Status RECRUITING

H.R.U Málaga - Hospital General

Málaga, , Spain

Site Status RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status RECRUITING

Royal Free Hospital

London, England, United Kingdom

Site Status RECRUITING

Local Institution - 0021

Glasgow, Glasgow City, United Kingdom

Site Status NOT_YET_RECRUITING

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Site Status RECRUITING

Local Institution - 0001

Newcastle upon Tyne, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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United States Australia Canada Chile France Italy Netherlands Spain United Kingdom

Central Contacts

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BMS Study Connect www.BMSStudyConnect.com

Role: CONTACT

Phone: 855-907-3286

Email: [email protected]

First line of the email MUST contain the NCT# and Site#

Role: CONTACT

Facility Contacts

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Site 0066

Role: primary

Gilberto DE LIMA LOPES JUNIOR, Site 0009

Role: primary

Site 0065

Role: primary

Martin Gutierrez, Site 0010

Role: primary

Khaled Hassan, Site 0029

Role: primary

Site 0102

Role: primary

Site 0052

Role: primary

Site 0090

Role: primary

Site 0103

Role: primary

Site 0092

Role: primary

Siddhartha Devarakonda, Site 0012

Role: primary

Abhijit Pal, Site 0027

Role: primary

Wen Xu, Site 0028

Role: primary

Quincy Chu, Site 0024

Role: primary

Site 0064

Role: primary

Scott Laurie, Site 0026

Role: primary

Marie Florescu, Site 0022

Role: primary

Jennifer Friedmann, Site 0025

Role: primary

Site 0048

Role: primary

Site 0049

Role: primary

Site 0047

Role: primary

Site 0077

Role: primary

Sophie Cousin, Site 0043

Role: primary

Site 0050

Role: primary

Site 0045

Role: primary

Benoit Roch, Site 0053

Role: primary

Site 0041

Role: primary

Site 0076

Role: primary

Site 0054

Role: primary

Jacques Cadranel, Site 0040

Role: primary

Alessandra Bearz, Site 0034

Role: primary

Site 0033

Role: primary

Site 0056

Role: primary

Site 0035

Role: primary

Site 0093

Role: primary

Site 0032

Role: primary

Egbert Smit, Site 0004

Role: primary

Gerrina Ruiter, Site 0003

Role: primary

Site 0062

Role: primary

Enriqueta Felip Font, Site 0016

Role: primary

Site 0058

Role: primary

Luis Paz-Ares Rodriguez, Site 0018

Role: primary

Site 0061

Role: primary

Ester García Lorenzo, Site 0017

Role: primary

Ramon Yarza Barrio, Site 0019

Role: primary

Manuel Cobo-Dols, Site 0063

Role: primary

Oscar Juan Vidal, Site 0060

Role: primary

Alexa Childs, Site 0030

Role: primary

Site 0021

Role: primary

Gary Middleton, Site 0020

Role: primary

Site 0001

Role: primary

Related Links

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Other Identifiers

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CA244-0001

Identifier Type: -

Identifier Source: org_study_id

2024-514947-27

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1308-2752

Identifier Type: OTHER

Identifier Source: secondary_id