drugset / Trial / NCT06926868
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)
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-09-11
- Primary completion
- 2028-03-13
- Completion
- 2030-05-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | — | — |
| Comparator | Carboplatin | Small molecule | — | — |
| Comparator | Gemcitabine | Small molecule | — | — |
| Subject | Izalontamab Brengitecan | Unknown | — | — |
| Comparator | Paclitaxel | Small molecule | — | — |