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)
NCT06926868 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2026-04-30
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.
Conditions
- Breast Neoplasms
Interventions
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
Sponsors & Collaborators
-
SystImmune Inc.
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-11
- Primary Completion
- 2028-03-13
- Completion
- 2030-05-15
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Brazil
- Canada
- Chile
- China
- Colombia
- France
- Germany
- Greece
- India
- Israel
- Italy
- Japan
- Mexico
- Poland
- Portugal
- Romania
- South Africa
- South Korea
- Spain
- Sweden
- Switzerland
- Turkey (Türkiye)
- United Arab Emirates
- United Kingdom
Study Locations
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