Status:
RECRUITING
A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Advanced Solid Tumor
Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 14 2028
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT06997029
Start Date
August 1 2025
End Date
December 14 2028
Last Update
January 5 2026
Active Locations (19)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
2
Providence St. Jude Medical Center
Fullerton, California, United States, 92835
3
Marin Cancer Care
Greenbrae, California, United States, 94904
4
Moores Cancer Center
La Jolla, California, United States, 92093