A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)

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

  • Breast Neoplasms

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