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

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumours

In brief

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

Key facts

Study ID

NCT07160725

Run by

Bristol-Myers Squibb

People needed

540

Starts

2025-10-15

Expected to finish

2028-08-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, Irvine (UCI) Health - UC Irvine Medical Center — Orange, California, United States (enrolling)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Clinica Universidad de Navarra — Pamplona, Navarre, Spain (enrolling)
• Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain (enrolling)
• Sanford Cancer Center — Sioux Falls, South Dakota, United States (enrolling)
• START - Dallas Fort Worth — Fort Worth, Texas, United States (enrolling)
• START San Antonio — San Antonio, Texas, United States (enrolling)
• START Mountain Region — West Valley City, Utah, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Herlev and Gentofte Hospital — Copenhagen, Capital Region, Denmark (enrolling)
• Odense Universitetshospital — Odense, Region Syddanmark, Denmark (enrolling)
• Copenhagen University Hospital Rigshospitalet — Copenhagen, Denmark (enrolling)
• National Cancer Center Hospital — Chuo-ku, Tokyo, Japan (enrolling)
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Local Institution - 0023 — Madrid, Spain
• Local Institution - 0026 — Málaga, Andalusia, Spain
• Local Institution - 0022 — Badalona, Barcelona [Barcelona], Spain
• Local Institution - 0024 — Barcelona, Barcelona [Barcelona], Spain
• Local Institution - 0033 — Irvine, California, United States

Full record on ClinicalTrials.gov

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