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Purpose

The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.

Condition

Eligibility

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

Inclusion Criteria

  • Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER < 1%, PgR < 1%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) per ASCO/CAP criteria, based on the most recently analyzed biopsy or other pathology specimen. - Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent. - Patients with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 or an anti-PD-L1 due to either one of the following criteria: i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC; ii) Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1; iii) Has a severe auto-immune disease or other contraindication. - Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments. - No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting). - Measurable disease by CT or MRI as per RECIST v1.1. - Other protocol-defined Inclusion/

Exclusion Criteria

apply.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A1
  • Drug: Iza-bren
    Specified dose on specified days
    Other names:
    • BMS-986507
    • BL-B01D1
    • Izalontamab brengitecan
Experimental
Arm A2
  • Drug: Iza-bren
    Specified dose on specified days
    Other names:
    • BMS-986507
    • BL-B01D1
    • Izalontamab brengitecan
Active Comparator
Arm B
  • Drug: Nab-paclitaxel
    Specified dose on specified days
  • Drug: Paclitaxel
    Specified dose on specified days
  • Drug: Capecitabine
    Specified dose on specified days
  • Drug: Carboplatin
    Specified dose on specified days
  • Drug: Gemcitabine
    Specified dose on specified days

Recruiting Locations

Helios Clinical Research
Cerritos, California 90703
Contact:
Omkar Marathe, Site 0328
562-693-4477

USC/Norris Comprehensive Cancer Center
Los Angeles, California 90033
Contact:
Daphne Stewart, Site 0290
323-865-3906

Valkyrie Clinical Trials
Los Angeles, California 90067
Contact:
David Berz, Site 0283
424-535-1874

USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California 92663
Contact:
Daphne Stewart, Site 0353
323-397-5954

Rocky Mountain Cancer Centers
Denver, Colorado 80220
Contact:
Mabel Mardones, Site 0367

Medical Oncology Hematology Consultants, PA
Newark, Delaware 19713
Contact:
Jamal Misleh, Site 0304
302-366-1200

Northside Hospital
Atlanta, Georgia 30342
Contact:
Amelia Zelnak, Site 0357
770-205-5292

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
James Wade, Site 0275
217-876-6611

Ochsner Clinic Foundation
Covington, Louisiana 70433
Contact:
Melanie Sheen, Site 0286
504-842-9780

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Neelima Vidula, Site 0288

Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Sara Tolaney, Site 0287
617-632-5743

Minnesota Oncology Hematology
Maple Grove, Minnesota 55369
Contact:
Eric Lander, Site 0313

Saint Luke's Cancer Institute
Kansas City, Missouri 64111
Contact:
Timothy Pluard, Site 0284
314-747-7992

Clinical Research Alliance
Westbury, New York 11590
Contact:
Jonathan Goldberg, Site 0295
914-242-2991

White Plains Hospital
White Plains, New York 10601
Contact:
Dan Costin, Site 0285
914-849-7630

Duke Cancer Institute
Durham, North Carolina 27710
Contact:
Carey Anders, Site 0276
919-684-0313

Willamette Valley Cancer Institute
Eugene, Oregon 97401
Contact:
Miho Dougherty, Site 0316

Lehigh Valley Health Network
Allentown, Pennsylvania 18103
Contact:
Nicholas Lamparella, Site 0356
610-402-9543

Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Payal Shah, Site 0310

St Francis Cancer Center
Greenville, South Carolina 29607
Contact:
Stephen Dyar, Site 0281
864-603-6327

Texas Oncology - Central/South Texas
Austin, Texas 78705
Contact:
Alvaro Restrepo, Site 0315

Texas Oncology - West Texas
El Paso, Texas 79902
Contact:
Ines Sanchez-Rivera, Site 0368
915-544-6750

Texas Oncology - Northeast Texas
Flower Mound, Texas 75028
Contact:
Vibha Thomas, Site 0305
303-925-0700

(USOR) Texas Oncology
Houston, Texas 77024-2843
Contact:
Dhatri Kodali, Site 0314
555-555-5555

Bon Secours St. Francis Medical Center
Midlothian, Virginia 23114
Contact:
William Irvin, Site 0277

Shenandoah Oncology, P.C.
Winchester, Virginia 22601
Contact:
William Houck, Site 0302
540-662-1108

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.