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

RECRUITINGPhase 1/2Sponsored by Bristol-Myers Squibb
Actively Recruiting
PhasePhase 1/2
SponsorBristol-Myers Squibb
Started2025-10-15
Est. completion2028-07-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations9 sites
View on ClinicalTrials.gov →

NCT07160725

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

Age: 18 Years+Healthy volunteers accepted
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 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.

Conditions2

CancerSolid Tumours

Locations9 sites

Local Institution - 0033
Irvine, California, 92612
Site 0033
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Anthony El-Khoueiry, Site 0002323-865-3967
Local Institution - 0021
Orange, California, 92868
Site 0021
Local Institution - 0008
Pittsburgh, Pennsylvania, 15232
Site 0008
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
Steven Powell, Site 0005605-328-8000

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