A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
Recruiting · NCT06997029 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
21 locations listed across 8 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- Providence St. Jude Medical Center - Fullerton, California, United States
- Marin Cancer Care - Greenbrae, California, United States
- Moores Cancer Center - La Jolla, California, United States
- Hoag Memorial Hospital Presbyterian - Newport Beach, California, United States
- Local Institution - 0008 - Aurora, Colorado, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Dartmouth-Hitchcock Medical Center - Lebanon, New Hampshire, United States
- Roswell Park Cancer Institute - Buffalo, New York, United States
- Northwell Health-Cancer Institute - New Hyde Park, New York, United States
- Local Institution - 0011 - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- START Dallas Fort Worth - Fort Worth, Texas, United States
- NEXT Oncology - San Antonio, Texas, United States
- Copenhagen University Hospital - Copenhagen, Denmark
- National Cancer Center Hospital East - Kashiwa, Chiba, Japan
- Kansai Medical University Hospital - Hirakata, Osaka, Japan
- Odense Universitetshospital - Odense, Region Syddanmark, Denmark
- National Cancer Center Hospital - Chuo-ku, Tokyo, Japan
- The Cancer Institute Hospital of JFCR - Koto-ku, Tokyo, Japan