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RecruitingInterventionalPhase 1/Phase 2

A Phase 1/2a, First-in-human, Open-label Study of BMS-986517 as Monotherapy in Adult Participants With Advanced Solid Tumors

NCT ID: NCT07160725Sponsor: Bristol-Myers SquibbLast updated: 2026-06-16

Summary

A phase 1/2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors

Arms & interventions

  • DrugBMS-986517

    Specified dose on specified days

Outcome measures

Primary

  • Number of Participants with Adverse Events (AE)

    Time frame: Up to approximately 2 years

  • Number of Participants with Serious Adverse Events (SAE)

    Time frame: Up to approximately 2 years

  • Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteria

    For part 1 only

    Time frame: Up to Day 21

  • Number of Participants with AEs Leading to Discontinuation

    Time frame: Up to approximately 2 years

  • Number of Participants with AEs Leading to Deaths

    Time frame: Up to approximately 2 years

Secondary

  • Objective Response Rate (ORR) Assessed by RECIST v1.1 per investigator assessment

    Time frame: Up to approximately 3 years

  • Duration of Response (DOR) Assessed by RECIST v1.1 per investigator assessment

    Time frame: Up to approximately 3 years

  • Maximum Plasma Concentration (Cmax)

    Time frame: Up to approximately 2 years

  • Time to Reach Maximum Plasma Concentration (Tmax)

    Time frame: Up to approximately 2 years

  • Area Under Curve (AUC)

    Time frame: Up to approximately 2 years

  • Total anti-drug antibodies (ADAs)

    Time frame: Up to approximately 2 Years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Participants must have an ECOG performance status of 0 to 1. * Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator). * Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+/HER2- breast cancer. Exclusion Criteria: * Participants must not have untreated CNS metastases. Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment). * Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment. * Participants must not have history of serious recurrent infections. * Participants must not have impaired cardiac function or history of severe heart disease. * Other protocol-defined inclusion/exclusion criteria apply.

Study locations (9)

Local Institution - 0033

Irvine, California, 92612

Not Yet Recruiting
Site 0033 · Contact

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Recruiting
Anthony El-Khoueiry, Site 0002 · Contact

University of California, Irvine (UCI) Health - UC Irvine Medical Center

Orange, California, 92868-3201

Recruiting
Rupali Nabar, Site 0021 · Contact

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Recruiting
Dan Zandberg, Site 0008 · Contact

Sanford Cancer Center

Sioux Falls, South Dakota, 57104

Recruiting
Steven Powell, Site 0005 · Contact

START - Dallas Fort Worth

Fort Worth, Texas, 76104

Recruiting
Henry Xiong, Site 0030 · Contact

START San Antonio

San Antonio, Texas, 78229

Recruiting
Drew Rasco, Site 0020 · Contact

START Mountain Region

West Valley City, Utah, 84119

Recruiting
William McKean, Site 0031 · Contact

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

Recruiting
Lauren Shih, Site 0028 · Contact