Clinical Trial

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 2/3
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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.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-08-11
notable Enrollment increased: 500 -> 600 participants 2026-08-11
Trial Details
NCT Number NCT06926868
Lead Sponsor Bristol-Myers Squibb
Collaborators: SystImmune Inc.
Conditions Breast Neoplasms
Enrollment 600 participants
Start Date 2025-09-11
Primary Completion 2028-03-13 (estimated)
Study Completion 2030-05-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-10