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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
View on ClinicalTrials.gov →
NCT06997029
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
Interventions3
Locations15 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Mehmet Akce, Site 0001205-975-0832
Hoag Memorial Hospital Presbyterian
Monica Mita, Site 0010949-764-4060
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Actively Recruiting
PhasePhase 1
SponsorBristol-Myers Squibb
Started2025-08-01
Est. completion2028-12-14
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations15 sites
View on ClinicalTrials.gov →
NCT06997029