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NCT07160725PHASE1, PHASE2Recruiting

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

Bristol-Myers Squibb

Start Date

10/15/2025

Completion Date

8/1/2028

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BMS-986517

DRUG

Pumitamig

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Conditions

Solid Tumours

Locations

Local Institution - 0033

Irvine, California 92612

United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

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

Orange, California 92868-3201

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

Sanford Cancer Center

Sioux Falls, South Dakota 57104

United States

START - Dallas Fort Worth

Fort Worth, Texas 76104

United States

START San Antonio

San Antonio, Texas 78229

United States

START Mountain Region

West Valley City, Utah 84119

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

Herlev and Gentofte Hospital

Copenhagen, Capital Region 2730

Denmark

Odense Universitetshospital

Odense, Region Syddanmark 5000

Denmark

Copenhagen University Hospital Rigshospitalet

Copenhagen, 2100

Denmark

National Cancer Center Hospital

Chuo-ku, Tokyo 104-0045

Japan

Local Institution - 0026

Málaga, Andalusia 29010

Spain

Local Institution - 0022

Badalona, Barcelona [Barcelona] 08916

Spain

Local Institution - 0024

Barcelona, Barcelona [Barcelona] 08035

Spain

Clinica Universidad de Navarra

Pamplona, Navarre 31008

Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040

Spain

Local Institution - 0023

Madrid, 28050

Spain