A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor, Advanced Breast Cancer, Advanced Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT06997029

Run by

Bristol-Myers Squibb

People needed

234

Starts

2025-08-01

Expected to finish

2028-12-14

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• The Cancer Institute Hospital of JFCR — Koto-ku, Tokyo, Japan (enrolling)
• Providence St. Jude Medical Center — Fullerton, California, United States (enrolling)
• Marin Cancer Care — Greenbrae, California, United States (enrolling)
• Moores Cancer Center — La Jolla, California, United States (enrolling)
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
• National Cancer Center Hospital — Chuo-ku, Tokyo, Japan (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
• Northwell Health-Cancer Institute — New Hyde Park, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• START Dallas Fort Worth — Fort Worth, Texas, United States (enrolling)
• NEXT Oncology — San Antonio, Texas, United States (enrolling)
• Odense Universitetshospital — Odense, Region Syddanmark, Denmark (enrolling)
• Copenhagen University Hospital — Copenhagen, Denmark (enrolling)
• National Cancer Center Hospital East — Kashiwa, Chiba, Japan (enrolling)
• Kansai Medical University Hospital — Hirakata, Osaka, Japan (enrolling)
• Local Institution - 0008 — Aurora, Colorado, United States
• Local Institution - 0011 — New York, New York, United States

Full record on ClinicalTrials.gov

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