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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06997029
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMS-986500 — DRUG
    Specified dose of specified days
  • Palbociclib — DRUG
    Specified dose on specified days
  • Fulvestrant — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Apr 2026
Primary completion
Dec 14, 2028
Completion
Dec 14, 2028

Study Design

Enrollment
234 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A Monotherapy Dose Escalation
  • Experimental: Part 1B Combination Dose Escalation
  • Experimental: Part 1C Monotherapy Pharmacodynamic (PD) Sub-study
  • Experimental: Part 2A Monotherapy Dose Expansion
  • Experimental: Part 2B Combination Dose Expansion

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Up to Day 28 From Last Dose ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (15)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-3300
Mehmet Akce, Site 0001
205-975-0832
Providence St. Jude Medical CenterFullertonCalifornia92835
Yung Lyou, Site 0003
714-446-5900
Marin Cancer CareGreenbraeCalifornia94904
Cyrus Mazidi, Site 0013
415-925-5000
Moores Cancer CenterLa JollaCalifornia92093
Peter Vu, Site 0009
858-822-2463
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663
Monica Mita, Site 0010
949-764-4060
Local Institution - 0008AuroraColorado80045
Site 0008
Dana-Farber Cancer InstituteBostonMassachusetts02215
Joyce Liu, Site 0006
617-632-5269
Washington University School of MedicineSt LouisMissouri63110
Faisal Fa'ak, Site 0004
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756
Lionel Lewis, Site 0002
603-381-1953
Roswell Park Cancer InstituteBuffaloNew York14263
Christos Fountzilas, Site 0014
716-574-7043
Northwell Health-Cancer InstituteNew Hyde ParkNew York11042
Geraldine O'Sullivan Coyne, Site 0016
Local Institution - 0011New YorkNew York10016
Site 0011
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Ezra Rosen, Site 0012
000-000-0000
START Dallas Fort WorthFort WorthTexas76104
Henry Xiong, Site 0018
682-350-3010
NEXT OncologySan AntonioTexas78229
David Sommerhalder, Site 0007
210-580-9500

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALProvidence St. Jude Medical Center· Fullerton, CAMarin Cancer Care· Greenbrae, CAMoores Cancer Center· La Jolla, CAHoag Memorial Hospital Presbyterian· Newport Beach, CALocal Institution - 0008· Aurora, CO

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