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RecruitingInterventionalPhase 1/Phase 2

A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

NCT ID: NCT07223047Sponsor: Bristol-Myers SquibbLast updated: 2026-05-28

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies

Arms & interventions

  • DrugBMS-986523

    Specified dose on specified days

  • DrugGemcitabine

    Specified dose on specified days

  • DrugNab-Paclitaxel

    Specified dose on specified days

  • DrugCetuximab

    Specified dose on specified days

  • DrugPembrolizumab

    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) criteria

    Time frame: Up to 3 years

  • Number of participants with AEs leading to discontinuation

    Time frame: Up to 3 years

  • Number of deaths

    Time frame: Up to 3 years

Secondary

  • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator.

    Time frame: Up to 3 years

  • Duration of response (DOR) per RECIST v1.1 as assessed by the investigator.

    Time frame: Up to 3 years

  • Maximum observed plasma concentration (Cmax)

    Time frame: Up to 3 years

  • Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to 3 years

  • Area under the concentration-time curve in 1 dosing interval (AUC(TAU))

    Time frame: Up to 3 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria * Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification). * Participants must, for Arm D, have a PD-L1 expression (≥50%). * Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments. Exclusion Criteria * Participants must not have untreated central nervous system (CNS) metastases. * Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment. * Participants must not have a history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis. A history of radiation pneumonitis in the radiation field is permitted. * Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). * Other protocol-defined Inclusion/Exclusion criteria apply.

Study locations (4)

Johns Hopkins Hospital

Baltimore, Maryland, 21287

Recruiting
Nilofer Azad, Site 0009 · Contact

NEXT Oncology

San Antonio, Texas, 78229

Recruiting
David Sommerhalder, Site 0001 · Contact

START Mountain Region

West Valley City, Utah, 84119

Recruiting
Justin Call, Site 0007 · Contact

NEXT Virginia

Fairfax, Virginia, 22031

Recruiting
Alexander Spira, Site 0011 · Contact