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)
Recruiting · Phase 2, Phase 3 · NCT06926868
Conditions: Breast Neoplasms
At a glance
- Research payments reported, 2025
- $42,615
- U.S. investigators named
- 32
- Sites paid
- 34
- Planned or actual enrollment
- 600
About the trial
- Sponsor
- Bristol-Myers Squibb (with SystImmune Inc.)
- Tested
- Iza-bren (drug), Nab-paclitaxel (drug), Paclitaxel (drug), Capecitabine (drug), Carboplatin (drug), Gemcitabine (drug)
- Dates
- Started 2025-09-11; completion 2030-05-15
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-08-10. Full record, eligibility and contacts (opens in a new tab)
Industry funding
E.r. Squibb & Sons, L.l.c. reported $42,615 in research payments for this study in 2025 (40 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- David Berz, MD, PHD, MPH Hematology & Oncology · Los Angeles, CA
- Steven Macina, DO Psychiatry · Huntington Beach, CA
- Omkar S. Marathe, MD Hematology & Oncology · Lakewood, CA
- Nandita Puchakayala, M.D. Psychiatry · Chino, CA
- Daphne B. Stewart, M.D Medical Oncology · Los Angeles, CA
- Mabel A. Mardones, M.D. Hematology & Oncology · Denver, CO
- Erin L. Schwab, M.D. Hematology & Oncology · Dillon, CO
- Rohan Garje, M.D Hematology & Oncology · Miami, FL
- Melanie A. Sheen, MD Hematology & Oncology · Tampa, FL
- James L. Wade III, M.D. Medical Oncology · Decatur, IL
- Zin W. Myint, M.D Medical Oncology · Lexington, KY
- Julia K. Rotow, MD Medical Oncology · Boston, MA
- Sara M. Tolaney, MD Hematology & Oncology · Boston, MA
- Neelima Vidula, M.D. Internal Medicine · Boston, MA
- Frank C. Cackowski, MD Medical Oncology · Ann Arbor, MI
- Carey K. Anders, M.D. Medical Oncology · Chapel Hill, NC
- Elyssa L. Barron, M.D. Psychiatry · White Plains, NY
- Dan Costin, MD Hematology & Oncology · White Plains, NY
- James D'olimpio Hematology & Oncology · Lake Success, NY
- Mehul P. Patel, MD Hematology & Oncology · Rochester, NY
- Ashish Saxena, MD, PHD Hematology & Oncology · Flushing, NY
- Rajwanth Veluswamy, MD Medical Oncology · New York, NY
- Rachel E. Sanborn, MD Medical Oncology · Portland, OR
- Melina E. Marmarelis, M.D. Internal Medicine · Philadelphia, PA
- Payal D. Shah, MD Medical Oncology · Philadelphia, PA
- Stephen H. Dyar JR., MD Hematology & Oncology · Greenville, SC
- Wade T. Iams, MD Hematology & Oncology · Nashville, TN
- Meredith S. Pelster, M.D. Hematology & Oncology · Nashville, TN
- David M. Gill Medical Oncology · Murray, UT
- Ryan D. Gentzler, M.D. Medical Oncology · Charlottesville, VA
- William J. Irvin JR., M.D. Hematology & Oncology · Midlothian, VA
- Renato G. Martins, MD, MPH Medical Oncology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Dana-Farber Cancer Institute $2,952
- Usc Norris Comprehensive Cancer Center $1,784
- Helios Clinical Research $1,782
- Rocky Mountain Cancer Center $1,752
- Duke Cancer Institute-Duke Univ. Medical Center $1,679
- St Francis Cancer Center $1,602
- Keck Medicine of Usc $1,594
- White Plains Hospital $1,585
- Bon Secours St. Francis Medical Center $1,572
- Valkyrie Global, Inc $1,525
- Clinical Research Alliance $1,470
- Decatur Memorial Hospital $1,460
- Cancer Care Specialists of Illinois $1,460
- Ochsner Medical Center Acute, LA $1,450
- Massachusetts General Hospital, MA $1,410
- Abramson Cancer Center of the University of Pennsylvania $1,410
- Pennsylvania Medicine $975
- Weill Cornell Medical College $975
- Rochester General Hospital Infectious Disease $973
- Virginia Commonwealth University (vcu) $969
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island $964
- NYU Langone Health $932
- Tennessee Oncology Centennial Clinic Drug Development Unit $924
- Sarah Cannon Research Institute $921
- Intermountain Medical Center, UT $907
- Baptist Health Medical Group Oncology Llc $906
- University of Virginia Health System $862
- Inland Psychiatric Medical Group, Inc $855
- Advanced Research Center $855
- Karmanos Cancer Center, MI $801
- Cenexel Atlanta $742
- University of Kentucky Chandler Medical Center $726
- Providence Portland Medical Center, OR $692
- Shaw Cancer Center $686
- $463
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.