Recruiting
A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
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.
ClinicalTrials.gov IDNCT06997029
PhasePHASE1
Enrollment234
SponsorBristol-Myers Squibb
Age18 Years
SexALL
Conditions studied
Advanced Solid Tumor, Advanced Breast Cancer, Advanced Ovarian Cancer
About this study
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.
Interventions
- Drug: BMS-986500 — Specified dose of specified days
- Drug: Palbociclib — Specified dose on specified days
- Drug: Fulvestrant — Specified dose on specified days
Primary outcomes
- Number of Participants With Dose Limiting Toxicities (DLTs) (Up to Day 28 From Last Dose)
- Number of Participants With Adverse Events (AEs) (Up to Day 28 From Last Dose)
- Number of Participants With Serious Adverse Events (SAEs) (Up to Day 28 From Last Dose)
- Number of Participants With AEs Leading to Discontinuation (Up to Day 28 From Last Dose)
- Number of Participants With TEAEs Leading to Death (Up to Day 28 From Last Dose)
Eligibility information
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.
Study locations
- University of Alabama at Birmingham, Birmingham, Alabama 35294-3300 United States
- Providence St. Jude Medical Center, Fullerton, California 92835 United States
- Marin Cancer Care, Greenbrae, California 94904 United States
- Moores Cancer Center, La Jolla, California 92093 United States
- Hoag Memorial Hospital Presbyterian, Newport Beach, California 92663 United States
- Local Institution - 0008, Aurora, Colorado 80045 United States
- Dana-Farber Cancer Institute, Boston, Massachusetts 02215 United States
- Washington University School of Medicine, St Louis, Missouri 63110 United States
- Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756 United States
- Roswell Park Cancer Institute, Buffalo, New York 14263 United States
Showing 10 of 21 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.