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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 1/2

A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 416 · Started: Feb 4, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06618287

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham, Birmingham
FloridaUniversity of Miami Hospital and Clinics, Sylvester Cancer Center, Miami
IowaLocal Institution - 0065, Iowa City (Not yet recruiting)
MissouriLocal Institution - 0140, St Louis (Not yet recruiting)
New JerseyJohn Theurer Cancer Center at Hackensack University Medical Center, Hackensack
OhioCleveland Clinic, Cleveland
Local Institution - 0102, Columbus (Not yet recruiting)
OregonLocal Institution - 0052, Portland (Not yet recruiting)
Providence Portland Medical Center, Portland
Providence St. Vincent Medical Center, Portland
TennesseeUniversity of Tennessee Medical Center, Knoxville
TexasNEXT Oncology - Irving, Irving
WashingtonSwedish Medical Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.