A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors
Sponsor: Bristol-Myers Squibb
Sponsor score: 60
ClinicalTrials ID:NCT07160725
This open-label study evaluates the safety and tolerability of BMS-986517 in participants with advanced solid tumors. Eligible participants must have an ECOG status of 0-1 and measurable disease per RECIST v1.1. Tumors must be histologically or cytologically confirmed as advanced, unresectable/metastatic, including NSCLC, HNSCC, TNBC, and HR+/HER2- breast cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
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 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0002 | 90033 | Los Angeles | California |
| Local Institution - 0021 | 92868 | Orange | California |
| Local Institution - 0008 | 15232 | Pittsburgh | Pennsylvania |
| Sanford Cancer Center | 57104 | Sioux Falls | South Dakota |
| START - Dallas Fort Worth | 76104 | Fort Worth | Texas |
| START San Antonio | 78229 | San Antonio | Texas |
| START Mountain Region | 84119 | West Valley City | Utah |
| Local Institution - 0028 | 98109 | Seattle | Washington |
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