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

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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 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.
* For participants in Part 1B and 2B: Active autoimmune disease or requirement for systemic immunosuppressive therapy.
* For participants in Part 1B and 2B: History of interstitial lung disease (ILD) or pneumonitis requiring systemic steroids, or current/suspected ILD/pneumonitis.
* For participants in Part 1B and 2B: Significant risk of hemorrhage, including tumor invasion of major vessels or recent clinically significant bleeding.
* Other protocol-defined Inclusion/Exclusion criteria apply.

About the study

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

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 540 · Started: Oct 15, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07160725

Locations in the U.S.

CaliforniaLocal Institution - 0033, Irvine (Not yet recruiting)
USC/Norris Comprehensive Cancer Center, Los Angeles
University of California, Irvine (UCI) Health - UC Irvine Medical Center, Orange
PennsylvaniaUPMC Hillman Cancer Center, Pittsburgh
South DakotaSanford Cancer Center, Sioux Falls
TexasSTART - Dallas Fort Worth, Fort Worth
START San Antonio, San Antonio
UtahSTART Mountain Region, West Valley City
WashingtonFred Hutchinson Cancer Center, Seattle

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