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

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

  • Advanced Solid Tumor
  • Advanced Breast Cancer
  • Advanced Ovarian Cancer

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