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RecruitingInterventionalPhase 1/Phase 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

NCT ID: NCT06618287Sponsor: Bristol-Myers SquibbLast updated: 2026-05-07

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.

Arms & interventions

  • DrugBMS-986507

    Specified dose on specified days

  • DrugOsimertinib

    Specified dose on specified days

  • DrugPembrolizumab

    Specified dose on specified days

  • DrugNivolumab

    Specified dose on specified days

  • DrugPumitamig

    Specified dose on specified days

Outcome measures

Primary

  • Number of participants with adverse events (AEs)

    Time frame: Up to 3 years

  • Number of participants with serious adverse events (SAEs)

    Time frame: Up to 3 years

  • Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera

    Time frame: Up to 3 years

  • Number of participants with AEs leading to discontinuation

    Time frame: Up to 3 years

  • Number of participants with AEs leading to death

    Time frame: Up to 3 years

  • Number of DLTs that occur during the DLT evaluation period

    Time frame: Up to 3 weeks

Secondary

  • Maximum observed serum concentration (Cmax)

    Time frame: Up to 3 years

  • Time of maximum observed concentration (Tmax)

    Time frame: Up to 3 years

  • Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Time frame: Up to 3 years

  • Area under the serum concentration-time curve within a dosing interval (AUC(TAU))

    Time frame: Up to 3 years

  • Objective response rate (ORR)

    Time frame: Up to 2 year

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (14)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Recruiting
Aakash Desai, Site 0066 · Contact

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, 33136

Recruiting
Gilberto DE LIMA LOPES JUNIOR, Site 0009 · Contact

Local Institution - 0125

Maywood, Illinois, 60153

Not Yet Recruiting
Site 0125 · Contact

Local Institution - 0065

Iowa City, Iowa, 52242

Not Yet Recruiting
Site 0065 · Contact

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting
Martin Gutierrez, Site 0010 · Contact

Cleveland Clinic

Cleveland, Ohio, 44195

Recruiting
Khaled Hassan, Site 0029 · Contact

Local Institution - 0102

Columbus, Ohio, 43212

Not Yet Recruiting
Site 0102 · Contact

Local Institution - 0134

Portland, Oregon, 97225

Not Yet Recruiting
Site 0134 · Contact

Local Institution - 0052

Portland, Oregon, 97239

Not Yet Recruiting
Site 0052 · Contact

Local Institution - 0090

Portland, Oregon, 97239

Not Yet Recruiting
Site 0090 · Contact

Local Institution - 0014

Pittsburgh, Pennsylvania, 15232

Withdrawn

Local Institution - 0103

Knoxville, Tennessee, 37920

Not Yet Recruiting
Site 0103 · Contact

NEXT Oncology - Irving

Irving, Texas, 75039

Recruiting
Michael Song, Site 0092 · Contact

Swedish Medical Center

Seattle, Washington, 98104

Recruiting
Siddhartha Devarakonda, Site 0012 · Contact