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RECRUITING

NCT06926868

PHASE2/PHASE3

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)

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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.

Official title: IZABRIGHT-Breast01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer (TNBC) or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2025-09-11

Completion Date

2030-05-15

Last Updated

2026-08-10

Healthy Volunteers

No

Conditions

Breast Neoplasms

Interventions

DRUG

Iza-bren

Specified dose on specified days

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

Inclusion Criteria * Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic triple-negative breast cancer (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 American Society of Clinical Oncology/College of American Pathologists (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. * Participants with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 (eg, pembrolizumab) or an anti-PD-L1 (eg, atezolizumab) due to any 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 standard of care (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, in the opinion of the investigator, for the use of an anti-PD(L)1 drug: iv) Any auto-immune disease that requires current immunosuppression (eg, methotrexate, cyclophosphamide, prednisone \> 10 mg/day). v) Prior auto-immune AE to peri-adjuvant ICI that required immunosuppression. vi) Current Graves' disease with ophthalmopathy or in need of radioiodine or in use of antithyroid medication. vii) Current or prior auto-immune diseases per below: A. Moderate to severe rheumatoid arthritis. B. Auto-immune hepatitis or cholangitis. C. Myasthenia gravis. D. Moderate-to-severe or poorly controlled inflammatory bowel disease. E. Multiple sclerosis. F. Lupus with kidney involvement or moderate to severe lupus. G. Auto-immune myocarditis. Note: if participant meets Inclusion Criteria 5b or 5c, unknown PDL1 results per local SOC are acceptable in these specific cases. * 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. Exclusion Criteria * Participants with a known germline breast cancer gene (BRCA) 1 or 2 mutation whose best 1L treatment option, in the opinion of the investigator, is a poli-ADP-ribose-polymerase inhibitors (PARPi). * Untreated symptomatic central nervous system (CNS) metastases. Participants are eligible if CNS metastases have been treated, and participants' neurological signs and symptoms have returned to baseline. In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization. Imaging performed within 28 days of randomization must document radiographic stability of CNS lesions and be performed after completion of any CNS directed therapy. * Leptomeningeal metastases. * Participants with history of severe heart disease including, but not limited to, any of the following: i) History of clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification II to IV, pericarditis, or significant pericardial effusion). ii) Myocardial infarction, uncontrolled angina, or stroke/transient ischemic attack within the past 6 months. iii) QTc (by Fridericia's formula) prolongation ≥ 450 msec for males and ≥ 470 msec for females, except for right bundle branch block. iv) Known LVEF \< 50%. * Prior therapy with iza-bren or any other ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload. * Other protocol-defined Inclusion/Exclusion criteria apply.

Locations (295)

Local Institution - 0303

Hot Springs, Arkansas, United States

Helios Clinical Research

Cerritos, California, United States

Local Institution - 0307

Cerritos, California, United States

Local Institution - 0308

Cerritos, California, United States

Local Institution - 0309

Cerritos, California, United States

Local Institution - 0311

Long Beach, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Local Institution - 0358

Stanford, California, United States

Local Institution - 0289

Aurora, Colorado, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Medical Oncology Hematology Consultants, PA

Newark, Delaware, United States

Local Institution - 0296

Pembroke Pines, Florida, United States

Local Institution - 0294

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

Local Institution - 0278

Chicago, Illinois, United States

Local Institution - 0280

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Local Institution - 0324

O'Fallon, Illinois, United States

Ochsner Clinic Foundation

Covington, Louisiana, United States

Local Institution - 1035

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Cancer- Detroit (Brigitte Harris Cancer Pavilion)

Detroit, Michigan, United States

Minnesota Oncology Hematology

Maple Grove, Minnesota, United States

Local Institution - 0372

Minneapolis, Minnesota, United States

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Local Institution - 0312

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Local Institution - 1037

Syracuse, New York, United States

Clinical Research Alliance

Westbury, New York, United States

White Plains Hospital

White Plains, New York, United States

Duke Cancer Institute

Durham, North Carolina, United States

Willamette Valley Cancer Institute

Eugene, Oregon, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Local Institution - 0360

Pittsburgh, Pennsylvania, United States

St Francis Cancer Center

Greenville, South Carolina, United States

Texas Oncology - Central/South Texas

Austin, Texas, United States

Texas Oncology - West Texas

El Paso, Texas, United States

Texas Oncology - Northeast Texas

Flower Mound, Texas, United States

(USOR) Texas Oncology

Houston, Texas, United States

Bon Secours St. Francis Medical Center

Midlothian, Virginia, United States

Local Institution - 0301

Roanoke, Virginia, United States

Shenandoah Oncology, P.C.

Winchester, Virginia, United States

Local Institution - 0011

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D., Argentina

Hospital Italiano de Córdoba

Córdoba, Córdoba Province, Argentina

Centro Privado de RMI Río Cuarto S.A. II

Río Cuarto, Córdoba Province, Argentina

Sanatorio Plaza

Rosario, Santa Fe Province, Argentina

Instituto Argentino de Diagnóstico y Tratamiento (IADT)

Buenos Aires, Argentina

Centro Oncologico Korben

Buenos Aires, Argentina

Instituto Alexander Fleming

Buenos Aires, Argentina

Local Institution - 0346

Buenos Aires, Argentina

Fundación Oncológica Mendoza

Mendoza, Argentina

Macquarie University

Macquarie University, New South Wales, Australia

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Grampians Health

Ballarat Central, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

St. John of God Subiaco Hospital

Subiaco, Western Australia, Australia

Medizinische Universität Graz

Graz, Styria, Austria

Medizinische Universitaet Innsbruck

Innsbruck, Tyrol, Austria

Uniklinikum Salzburg

Salzburg, Austria

Universitätsklinikum St. Pölten

Sankt Pölten, Austria

Medizinische Universität Wien

Vienna, Austria

Local Institution - 0187

Manaus, Amazonas, Brazil

Oncocentro Oncologia

Fortaleza, Ceará, Brazil

CEDOES

Vitória, Espírito Santo, Brazil

Local Institution - 1038

Lago Sul, Federal District, Brazil

Centro Integrado de Oncologia de Curitiba

Curitiba, Paraná, Brazil

Futtura Oncology - Clinical Research Hub

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Local Institution - 0164

São José do Rio Preto, São Paulo, Brazil

Instituto Nacional de Câncer - INCA

Rio de Janeiro, Brazil

Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda

São Paulo, Brazil

Instituto D'Or de Pesquisa e Ensino (IDOR)

São Paulo, Brazil

BC Cancer Kelowna

Kelowna, British Columbia, Canada

Local Institution - 0217

Victoria, British Columbia, Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Centre Intégré de Santé et de Services Sociaux de Lanaudière

Saint-Charles-Borromée, Quebec, Canada

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUS

Sherbrooke, Quebec, Canada

FALP

Santiago, Santiago Metropolitan, Chile

Clínica Alemana de Santiago

Santiago, Santiago Metropolitan, Chile

Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, Chile

Bradfordhill

Santiago, Santiago Metropolitan, Chile

Oncocentro Apys

Viña del Mar, Valparaiso, Chile

Anhui Provincial Hospital

Hefei, Anhui, China

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, BEI, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Fujian Medical University Union Hospital

Fyzhou, Fujian, China

Local Institution - 1016

Xiamen, Fujian, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Guangxi Medical University Affiliated Cancer Hospital

Nanning, Guangxi, China

And 195 more locations on ClinicalTrials.gov