RECRUITING

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

Description

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.

Conditions

Advanced Solid TumorAdvanced Breast CancerAdvanced Ovarian Cancer
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Related Conditions:

Advanced Solid TumorAdvanced Breast CancerAdvanced Ovarian Cancer

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Birmingham

Local Institution - 0001, Birmingham, Alabama, United States, 35294-3300

Fullerton

Local Institution - 0003, Fullerton, California, United States, 92835

Greenbrae

Marin Cancer Care, Greenbrae, California, United States, 94904

La Jolla

Local Institution - 0009, La Jolla, California, United States, 92093

Newport Beach

Local Institution - 0010, Newport Beach, California, United States, 92663

Aurora

Local Institution - 0008, Aurora, Colorado, United States, 80045

Boston

Local Institution - 0006, Boston, Massachusetts, United States, 02215

Saint Louis

Local Institution - 0004, Saint Louis, Missouri, United States, 63110

Lebanon

Local Institution - 0002, Lebanon, New Hampshire, United States, 03756

Buffalo

Local Institution - 0014, Buffalo, New York, United States, 14263

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2028-12-14