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
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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RECRUITING
PHASE1/PHASE2
416 participants
INTERVENTIONAL
2025-02-04
2031-02-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group A
BMS-986507
Specified dose on specified days
Osimertinib
Specified dose on specified days
Group B
BMS-986507
Specified dose on specified days
Pembrolizumab
Specified dose on specified days
Group C
BMS-986507
Specified dose on specified days
Nivolumab
Specified dose on specified days
Group D
BMS-986507
Specified dose on specified days
Pumitamig
Specified dose on specified days
Group E
BMS-986507
Specified dose on specified days
Pumitamig
Specified dose on specified days
Interventions
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BMS-986507
Specified dose on specified days
Osimertinib
Specified dose on specified days
Pembrolizumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Pumitamig
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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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
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States
Local Institution - 0065
Iowa City, Iowa, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Cleveland Clinic
Cleveland, Ohio, United States
Local Institution - 0102
Columbus, Ohio, United States
Local Institution - 0052
Portland, Oregon, United States
Local Institution - 0090
Portland, Oregon, United States
Local Institution - 0014
Pittsburgh, Pennsylvania, United States
Local Institution - 0103
Knoxville, Tennessee, United States
Local Institution - 0092
Irving, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
Local Institution - 0064
Newmarket, Ontario, Canada
Local Institution - 0023
Ottawa, Ontario, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Local Institution - 0048
Santiago, Santiago Metropolitan, Chile
Local Institution - 0049
Santiago, Santiago Metropolitan, Chile
Local Institution - 0047
Santiago, Santiago Metropolitan, Chile
Local Institution - 0077
Nice, Alpes-Maritimes, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, Aquitaine, France
Local Institution - 0050
Lyon, Auvergne-Rhône-Alpes, France
Local Institution - 0045
Marseille, Bouches-du-Rhône, France
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, Hérault, France
Local Institution - 0041
Villejuif, Val-de-Marne, France
Local Institution - 0076
Caen, , France
Local Institution - 0054
Paris, , France
Hôpital Tenon
Paris, , France
Cro-Irccs
Aviano, Friuli Venezia Giulia, Italy
Local Institution - 0033
Milan, Lombardy, Italy
Local Institution - 0056
Candiolo, Torino, Italy
Local Institution - 0035
Florence, Tuscany, Italy
Local Institution - 0093
Milan, , Italy
Local Institution - 0032
Roma, , Italy
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)
Amsterdam, , Netherlands
Local Institution - 0062
Santiago de Compostela, A Coruña [La Coruña], Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0058
Hospitalet, Barcelona [Barcelona], Spain
Local Institution - 0059
Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0061
Majadahonda, Madrid, Comunidad de, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
H.R.U Málaga - Hospital General
Málaga, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Royal Free Hospital
London, England, United Kingdom
Local Institution - 0021
Glasgow, Glasgow City, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Local Institution - 0001
Newcastle upon Tyne, , United Kingdom
Countries
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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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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
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