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A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors

RECRUITINGPhase 1Sponsored by Bristol-Myers Squibb
Actively Recruiting
PhasePhase 1
SponsorBristol-Myers Squibb
Started2025-08-01
Est. completion2028-12-14
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations15 sites

Summary

The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Participants must be ≥ 18 years of age.
* Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.
* Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* For Part 2A only, participants must have CCNE1-amplified ovarian cancer

Exclusion Criteria:

* Participants must not have an active brain metastasis.
* Participants must not have impaired cardiac function or clinically significant cardiac disease.
* Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.
* Participants must not have Grade ≥ 2 peripheral neuropathy.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Conditions5

Advanced Breast CancerAdvanced Ovarian CancerAdvanced Solid TumorBreast CancerCancer

Locations15 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Mehmet Akce, Site 0001205-975-0832
Providence St. Jude Medical Center
Fullerton, California, 92835
Yung Lyou, Site 0003714-446-5900
Marin Cancer Care
Greenbrae, California, 94904
Cyrus Mazidi, Site 0013415-925-5000
Moores Cancer Center
La Jolla, California, 92093
Peter Vu, Site 0009858-822-2463
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Monica Mita, Site 0010949-764-4060

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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