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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

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Brian Van Tine, Site 0004
314-747-3096

More Details

NCT ID
NCT06997029
Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Study Connect Contact Center, 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.