Status:
RECRUITING
A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Solid Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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
Inclusion
- 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
- 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.
- Other protocol-defined inclusion/exclusion criteria apply.
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT07160725
Start Date
October 15 2025
End Date
August 1 2028
Last Update
February 17 2026
Active Locations (19)
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1
Local Institution - 0033
Irvine, California, United States, 92612
2
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
Local Institution - 0021
Orange, California, United States, 92868
4
Local Institution - 0008
Pittsburgh, Pennsylvania, United States, 15232