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

NCT07160725

RecruitingPhase 1, Phase 2

Sponsor: Bristol-Myers Squibb

Conditions: Solid Tumours

Interventions: BMS-986517, Pumitamig

Countries: United States, Denmark, Japan, Spain

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (19)
  • Irvine, California, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • Pittsburgh, Pennsylvania, United States
  • Sioux Falls, South Dakota, United States
  • Fort Worth, Texas, United States
  • San Antonio, Texas, United States
  • West Valley City, Utah, United States
  • Seattle, Washington, United States
  • Copenhagen, Capital Region, Denmark
  • Odense, Region Syddanmark, Denmark
  • Copenhagen, Denmark
  • Chuo-ku, Tokyo, Japan
  • Málaga, Andalusia, Spain
  • Badalona, Barcelona [Barcelona], Spain
  • Barcelona, Barcelona [Barcelona], Spain
  • Pamplona, Navarre, Spain
  • Madrid, Spain
  • Madrid, Spain