Trials / Recruiting
RecruitingNCT06926868
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)
IZABRIGHT-Breast01: A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer (TNBC) or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Iza-bren | Specified dose on specified days |
| DRUG | Nab-paclitaxel | Specified dose on specified days |
| DRUG | Paclitaxel | Specified dose on specified days |
| DRUG | Capecitabine | Specified dose on specified days |
| DRUG | Carboplatin | Specified dose on specified days |
| DRUG | Gemcitabine | Specified dose on specified days |
Timeline
- Start date
- 2025-09-11
- Primary completion
- 2028-03-13
- Completion
- 2030-05-15
- First posted
- 2025-04-15
- Last updated
- 2026-04-01
Locations
293 sites across 28 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06926868. Inclusion in this directory is not an endorsement.