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 now · Phase 2/Phase 3

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT06926868

Run by

Bristol-Myers Squibb

People needed

500

Starts

2025-09-11

Expected to finish

2030-05-15

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Lehigh Valley Health Network — Allentown, Pennsylvania, United States (enrolling)
• Texas Oncology - West Texas — El Paso, Texas, United States (enrolling)
• Saint Luke's Cancer Institute — Kansas City, Missouri, United States (enrolling)
• Willamette Valley Cancer Institute — Eugene, Oregon, United States (enrolling)
• Abramson Cancer Center of The University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Texas Oncology - Central/South Texas — Austin, Texas, United States (enrolling)
• Helios Clinical Research — Cerritos, California, United States (enrolling)
• Minnesota Oncology Hematology — Maple Grove, Minnesota, United States (enrolling)
• Clinical Research Alliance — Westbury, New York, United States (enrolling)
• Duke Cancer Institute — Durham, North Carolina, United States (enrolling)
• Rocky Mountain Cancer Centers — Denver, Colorado, United States (enrolling)
• Medical Oncology Hematology Consultants, PA — Newark, Delaware, United States (enrolling)
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• St Francis Cancer Center — Greenville, South Carolina, United States (enrolling)
• Northside Hospital — Atlanta, Georgia, United States (enrolling)
• Valkyrie Clinical Trials — Los Angeles, California, United States (enrolling)
• USC Norris Oncology/Hematology-Newport Beach — Newport Beach, California, United States (enrolling)
• Decatur Memorial Hospital — Decatur, Illinois, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Ochsner Clinic Foundation — Covington, Louisiana, United States (enrolling)
• White Plains Hospital — White Plains, New York, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Henry Ford Cancer- Detroit (Brigitte Harris Cancer Pavilion) — Detroit, Michigan, United States (enrolling)
• Texas Oncology - Northeast Texas — Flower Mound, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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