A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4/6 Inhibitor Pre-treated Advanced Breast Cancer
Bristol-Myers Squibb
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 range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 car…
Interventions
- DrugBMS-986500
Specified dose of specified days
- DrugPalbociclib
Specified dose on specified days
- DrugFulvestrant
Specified dose on specified days
Locations (21)
- University of Alabama at BirminghamBirmingham, Alabama
- Providence St. Jude Medical CenterFullerton, California
- Marin Cancer CareGreenbrae, California
- Moores Cancer CenterLa Jolla, California
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- Local Institution - 0008Aurora, Colorado