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
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
California
Providence St. Jude Medical Center
RECRUITING
Fullerton
Marin Cancer Care
RECRUITING
Greenbrae
Moores Cancer Center
RECRUITING
La Jolla
Local Institution - 0010
NOT_YET_RECRUITING
Newport Beach
Colorado
Local Institution - 0008
NOT_YET_RECRUITING
Aurora
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Missouri
Washington University School of Medicine
RECRUITING
St Louis
New Hampshire
Local Institution - 0002
NOT_YET_RECRUITING
Lebanon
New York
Local Institution - 0014
NOT_YET_RECRUITING
Buffalo
Northwell Health-Cancer Institute
RECRUITING
New Hyde Park
Local Institution - 0011
NOT_YET_RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Texas
START Dallas Fort Worth
RECRUITING
Fort Worth
NEXT Oncology
RECRUITING
San Antonio
Other Locations
Japan
Local Institution - 0022
NOT_YET_RECRUITING
Chuo-ku
Local Institution - 0020
NOT_YET_RECRUITING
Hirakata-shi
Local Institution - 0021
NOT_YET_RECRUITING
Kashiwa
Local Institution - 0023
NOT_YET_RECRUITING
Koto-ku
Contact Information
Primary
BMS Study Connect Contact Center, www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain he NCT# and Site #.
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2028-12-14
Participants
Target number of participants: 234
Treatments
Experimental: Part 1A Monotherapy Dose Escalation
Experimental: Part 1B Combination Dose Escalation
Experimental: Part 1C Monotherapy Pharmacodynamic (PD) Sub-study
Experimental: Part 2A Monotherapy Dose Expansion
Experimental: Part 2B Combination Dose Expansion
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb