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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1A Monotherapy Dose Escalation
  • Drug: BMS-986500
    Specified dose of specified days
Experimental
Part 1B Combination Dose Escalation
  • Drug: BMS-986500
    Specified dose of specified days
  • Drug: Palbociclib
    Specified dose on specified days
    Other names:
    • IBRANCE®
    • PD 0332991
  • Drug: Fulvestrant
    Specified dose on specified days
    Other names:
    • FASLODEX®
Experimental
Part 1C Monotherapy Pharmacodynamic (PD) Sub-study
  • Drug: BMS-986500
    Specified dose of specified days
Experimental
Part 2A Monotherapy Dose Expansion
  • Drug: BMS-986500
    Specified dose of specified days
Experimental
Part 2B Combination Dose Expansion
  • Drug: BMS-986500
    Specified dose of specified days
  • Drug: Palbociclib
    Specified dose on specified days
    Other names:
    • IBRANCE®
    • PD 0332991
  • Drug: Fulvestrant
    Specified dose on specified days
    Other names:
    • FASLODEX®

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294-3300
Contact:
Mehmet Akce, Site 0001
205-975-0832

Providence St. Jude Medical Center
Fullerton, California 92835
Contact:
Yung Lyou, Site 0003
714-446-5900

Marin Cancer Care
Greenbrae, California 94904
Contact:
Cyrus Mazidi, Site 0013
415-925-5000

Moores Cancer Center
La Jolla, California 92093
Contact:
Peter Vu, Site 0009
858-822-2463

Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
Contact:
Monica Mita, Site 0010
949-764-4060

Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Joyce Liu, Site 0006
617-632-5269

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Faisal Fa'ak, Site 0004

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
Contact:
Lionel Lewis, Site 0002
603-381-1953

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Christos Fountzilas, Site 0014
716-574-7043

Northwell Health-Cancer Institute
New Hyde Park, New York 11042
Contact:
Geraldine O'Sullivan Coyne, Site 0016

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Ezra Rosen, Site 0012
000-000-0000

START Dallas Fort Worth
Fort Worth, Texas 76104
Contact:
Henry Xiong, Site 0018
682-350-3010

NEXT Oncology
San Antonio, Texas 78229
Contact:
David Sommerhalder, Site 0007
210-580-9500

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.