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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Iza-bren: Specified dose on specified days
Nab-paclitaxel: Specified dose on specified days
Paclitaxel: Specified dose on specified days
Capecitabine: Specified dose on specified days
Carboplatin: Specified dose on specified days
Gemcitabine: Specified dose on specified days
Study 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.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) — Approximately 22 months from first participant randomization in Phase 3
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR) - Recommended Phase 3 Dose (RP3D) of BMS-986507 — Approximately 13 months from first participant randomization in Phase 2
Trial sites (295)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 0303 | Hot Springs | Arkansas | Not Yet Recruiting |
| Helios Clinical Research | Cerritos | California | Recruiting |
| Local Institution - 0307 | Cerritos | California | Withdrawn |
| Local Institution - 0308 | Cerritos | California | Withdrawn |
| Local Institution - 0309 | Cerritos | California | Withdrawn |
| Local Institution - 0311 | Long Beach | California | Withdrawn |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| Valkyrie Clinical Trials | Los Angeles | California | Recruiting |
| USC Norris Oncology/Hematology-Newport Beach | Newport Beach | California | Recruiting |
| Local Institution - 0358 | Stanford | California | Not Yet Recruiting |
| Local Institution - 0289 | Aurora | Colorado | Not Yet Recruiting |
| Rocky Mountain Cancer Centers | Denver | Colorado | Recruiting |
| Medical Oncology Hematology Consultants, PA | Newark | Delaware | Recruiting |
| Local Institution - 0296 | Pembroke Pines | Florida | Not Yet Recruiting |
| Local Institution - 0294 | Atlanta | Georgia | Completed |
| Northside Hospital | Atlanta | Georgia | Recruiting |
| Local Institution - 0278 | Chicago | Illinois | Withdrawn |
| Local Institution - 0280 | Chicago | Illinois | Not Yet Recruiting |
| Decatur Memorial Hospital | Decatur | Illinois | Recruiting |
| Local Institution - 0324 | O'Fallon | Illinois | Withdrawn |
| Ochsner Clinic Foundation | Covington | Louisiana | Recruiting |
| Local Institution - 1035 | Baltimore | Maryland | Not Yet Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Henry Ford Cancer- Detroit (Brigitte Harris Cancer Pavilion) | Detroit | Michigan | Recruiting |
| Minnesota Oncology Hematology | Maple Grove | Minnesota | Recruiting |
| Local Institution - 0372 | Minneapolis | Minnesota | Not Yet Recruiting |
| Saint Luke's Cancer Institute | Kansas City | Missouri | Recruiting |
| Local Institution - 0312 | New York | New York | Withdrawn |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Local Institution - 1037 | Syracuse | New York | Not Yet Recruiting |
| Clinical Research Alliance | Westbury | New York | Recruiting |
| White Plains Hospital | White Plains | New York | Recruiting |
| Duke Cancer Institute | Durham | North Carolina | Recruiting |
| Willamette Valley Cancer Institute | Eugene | Oregon | Recruiting |
| Lehigh Valley Health Network | Allentown | Pennsylvania | Recruiting |
| Abramson Cancer Center of The University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| Local Institution - 0360 | Pittsburgh | Pennsylvania | Not Yet Recruiting |
| St Francis Cancer Center | Greenville | South Carolina | Recruiting |
| Texas Oncology - Central/South Texas | Austin | Texas | Recruiting |
+ 255 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06926868 on ClinicalTrials.gov ↗ ← All trials in Italy