A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors

Purpose

A phase 1/2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors

Condition

  • Solid Tumours

Eligibility

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

Inclusion Criteria

  • Participants must have an ECOG performance status of 0 to 1. - Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator). - Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+/HER2- breast cancer.

Exclusion Criteria

  • Participants must not have untreated CNS metastases. Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment). - Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment. - Participants must not have history of serious recurrent infections. - Participants must not have impaired cardiac function or history of severe heart disease. - Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1
  • Drug: BMS-986517
    Specified dose on specified days
Experimental
Part 2: Cohort A
  • Drug: BMS-986517
    Specified dose on specified days
Experimental
Part 2: Cohort B
  • Drug: BMS-986517
    Specified dose on specified days
Experimental
Part 2: Cohort C
  • Drug: BMS-986517
    Specified dose on specified days

Recruiting Locations

Sanford Cancer Center
Sioux Falls 5231851, South Dakota 5769223 57104
Contact:
Steven Powell, Site 0005
605-328-8000

START - Dallas Fort Worth
Fort Worth 4691930, Texas 4736286 76104
Contact:
Henry Xiong, Site 0030
682-350-3010

START San Antonio
San Antonio 4726206, Texas 4736286 78229
Contact:
Drew Rasco, Site 0020
210-593-5250

START Mountain Region
West Valley City 5784607, Utah 5549030 84119
Contact:
William McKean, Site 0031
801-907-4750

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
8559073286
Clinical.Trials@bms.com