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)

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER < 1%, PgR < 1%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) per ASCO/CAP criteria, based on the most recently analyzed biopsy or other pathology specimen.
• Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.
• Patients with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 or an anti-PD-L1 due to either one of the following criteria: i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC; ii) Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1; iii) Has a severe auto-immune disease or other contraindication.
• Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.
• No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting).
• Measurable disease by CT or MRI as per RECIST v1.1.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

• Local Institution - 0303, Hot Springs, Arkansas, United States
• Helios Clinical Research, Cerritos, California, United States
• Local Institution - 0307, Cerritos, California, United States
• Local Institution - 0308, Cerritos, California, United States
• Local Institution - 0309, Cerritos, California, United States
• Local Institution - 0311, Long Beach, California, United States
• USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
• Valkyrie Clinical Trials, Los Angeles, California, United States
• USC Norris Oncology/Hematology-Newport Beach, Newport Beach, California, United States
• Local Institution - 0358, Stanford, California, United States
• Local Institution - 0289, Aurora, Colorado, United States
• Rocky Mountain Cancer Centers, Denver, Colorado, United States

+ 283 more sites.

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06926868.