A Phase I 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
Study Identifier:
CA2430001
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
Study Contact Information:
N/A
Recruiting
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Study 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.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
Female & Male
Age
18+ years
Study Drug
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START New York (Long Island)
Lake Success, NY, United States, 11042
Investigator
Geraldine O'Sullivan Coyne
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor
Breast Cancers
Ovarian
Location
START Dallas Fort Worth
Fort Worth, TX, United States, 76104
Investigator
Henry Xiong
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor
Breast Cancers
Ovarian