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 (13) 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
Local Institution - 0001
NOT_YET_RECRUITING
Birmingham
California
Local Institution - 0003
NOT_YET_RECRUITING
Fullerton
Marin Cancer Care
RECRUITING
Greenbrae
Local Institution - 0009
NOT_YET_RECRUITING
La Jolla
Local Institution - 0010
NOT_YET_RECRUITING
Newport Beach
Colorado
Local Institution - 0008
NOT_YET_RECRUITING
Aurora
Massachusetts
Local Institution - 0006
NOT_YET_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
Local Institution - 0011
NOT_YET_RECRUITING
New York
Local Institution - 0012
NOT_YET_RECRUITING
New York
Texas
NEXT Oncology
RECRUITING
San Antonio
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