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

NCT06997029

RecruitingPhase 1

Sponsor: Bristol-Myers Squibb

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

Interventions: BMS-986500, Palbociclib, Fulvestrant

Countries: United States, Denmark, Japan

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (21)
  • Birmingham, Alabama, United States
  • Fullerton, California, United States
  • Greenbrae, California, United States
  • La Jolla, California, United States
  • Newport Beach, California, United States
  • Aurora, Colorado, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, United States
  • Lebanon, New Hampshire, United States
  • Buffalo, New York, United States
  • New Hyde Park, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Fort Worth, Texas, United States
  • San Antonio, Texas, United States
  • Odense, Region Syddanmark, Denmark
  • Copenhagen, Denmark
  • Kashiwa, Chiba, Japan
  • Hirakata, Osaka, Japan
  • Chuo-ku, Tokyo, Japan
  • Koto-ku, Tokyo, Japan