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)
View Full Details on ClinicalTrials.gov
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NCT07160725
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