RecruitingRecruiting
A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
NCT06997029 · Bristol-Myers Squibb
In plain English
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Official title
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
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.
Eligibility criteria
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 design
Enrollment target: 234 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-08-01
Estimated completion: 2028-12-14
Last updated: 2026-07-10
Interventions
Drug: BMS-986500Drug: PalbociclibDrug: Fulvestrant
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)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (21)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Providence St. Jude Medical CenterRecruiting
Fullerton, California, United States
Marin Cancer CareRecruiting
Greenbrae, California, United States
Moores Cancer CenterRecruiting
La Jolla, California, United States
Hoag Memorial Hospital PresbyterianRecruiting
Newport Beach, California, United States
Local Institution - 0008Not Yet Recruiting
Aurora, Colorado, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical CenterRecruiting
Lebanon, New Hampshire, United States
Roswell Park Cancer InstituteRecruiting
Buffalo, New York, United States
Northwell Health-Cancer InstituteRecruiting
New Hyde Park, New York, United States
Local Institution - 0011Not Yet Recruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
START Dallas Fort WorthRecruiting
Fort Worth, Texas, United States
NEXT OncologyRecruiting
San Antonio, Texas, United States
Odense UniversitetshospitalRecruiting
Odense, Region Syddanmark, Denmark
Copenhagen University HospitalRecruiting
Copenhagen, Denmark
National Cancer Center Hospital EastRecruiting
Kashiwa, Chiba, Japan
Kansai Medical University HospitalRecruiting
Hirakata, Osaka, Japan
National Cancer Center HospitalRecruiting
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCRRecruiting
Koto-ku, Tokyo, Japan