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Purpose

The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.

Conditions

Eligibility

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

Inclusion Criteria

  • Participants must have at least one measurable lesion per response evaluation criteria in solid tumors. - Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. - Participants must have a life expectancy of at least 3 months at the time of the first dose. - Group A: Participants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, which may include T790M in exon 20. Participants with other EGFR mutations (including but not limited to, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations, etc.) will also be allowed - Group B: Participants must have pathologically confirmed locally advanced or metastatic NSCLC. - Group C: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC or ER-low, HER2-negative BC. - Group D: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC per ASCO/CAP criteria, based on the most recently analyzed biopsy or another pathology specimen. - Group E: Participants must have pathologically confirmed locally advanced or metastatic NSCLC, not amenable to treatment in curative intent.

Exclusion Criteria

  • Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology. - Participants with known mutations in EGFR will be excluded (Group A,B and E). - Participants must not have a history of serious recurrent infections. - Participants must not have a 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
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group A
  • Drug: BMS-986507
    Specified dose on specified days
    Other names:
    • Iza-bren
    • Izalontamab brengitecan
  • Drug: Osimertinib
    Specified dose on specified days
Experimental
Group B
  • Drug: BMS-986507
    Specified dose on specified days
    Other names:
    • Iza-bren
    • Izalontamab brengitecan
  • Drug: Pembrolizumab
    Specified dose on specified days
Experimental
Group C
  • Drug: BMS-986507
    Specified dose on specified days
    Other names:
    • Iza-bren
    • Izalontamab brengitecan
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo
    • BMS-936558
Experimental
Group D
  • Drug: BMS-986507
    Specified dose on specified days
    Other names:
    • Iza-bren
    • Izalontamab brengitecan
  • Drug: Pumitamig
    Specified dose on specified days
    Other names:
    • BMS-986545
    • BNT327
    • PM8002
Experimental
Group E
  • Drug: BMS-986507
    Specified dose on specified days
    Other names:
    • Iza-bren
    • Izalontamab brengitecan
  • Drug: Pumitamig
    Specified dose on specified days
    Other names:
    • BMS-986545
    • BNT327
    • PM8002

Recruiting Locations

University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami 4164138, Florida 4155751 33136
Contact:
Gilberto DE LIMA LOPES JUNIOR, Site 0009
305-243-1086

John Theurer Cancer Center at Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
Contact:
Martin Gutierrez, Site 0010
551-996-5863

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Contact:
Khaled Hassan, Site 0029
734-615-2939

Swedish Medical Center
Seattle 5809844, Washington 5815135 98104
Contact:
Siddhartha Devarakonda, Site 0012
206-386-2457

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.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.