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A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors
RECRUITINGPhase 1/2Sponsored by Bristol-Myers Squibb
Actively Recruiting
PhasePhase 1/2
SponsorBristol-Myers Squibb
Started2025-02-04
Est. completion2031-02-26
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations12 sites
View on ClinicalTrials.gov →
NCT06618287
Summary
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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.
Conditions3
Breast CancerCancerLung Cancer
Locations12 sites
Local Institution - 0066
Birmingham, Alabama, 35294-3300
Site 0066
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136
Gilberto DE LIMA LOPES JUNIOR, Site 0009305-243-1086
Local Institution - 0065
Iowa City, Iowa, 52242
Site 0065
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Martin Gutierrez, Site 0010551-996-5863
Cleveland Clinic
Cleveland, Ohio, 44195
Khaled Hassan, Site 0029734-615-2939
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Actively Recruiting
PhasePhase 1/2
SponsorBristol-Myers Squibb
Started2025-02-04
Est. completion2031-02-26
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations12 sites
View on ClinicalTrials.gov →
NCT06618287