RecruitingPhase 1Phase 2NCT07160725

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

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


Sponsor

Bristol-Myers Squibb

Enrollment

315 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

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Interventions

DRUGBMS-986517

Specified dose on specified days


Locations(19)

Local Institution - 0033

Irvine, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Local Institution - 0021

Orange, California, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Sanford Cancer Center

Sioux Falls, South Dakota, United States

START - Dallas Fort Worth

Fort Worth, Texas, United States

START San Antonio

San Antonio, Texas, United States

START Mountain Region

West Valley City, Utah, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Herlev and Gentofte Hospital

Copenhagen, Capital Region, Denmark

Odense Universitetshospital

Odense, Region Syddanmark, Denmark

Copenhagen University Hospital Rigshospitalet

Copenhagen, Denmark

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Local Institution - 0026

Málaga, Andalusia, Spain

Local Institution - 0022

Badalona, Barcelona [Barcelona], Spain

Local Institution - 0024

Barcelona, Barcelona [Barcelona], Spain

Local Institution - 0025

Pamplona, Navarre, Spain

Local Institution - 0027

Madrid, Spain

Local Institution - 0023

Madrid, Spain

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NCT07160725


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