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)

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.

Trial Details

NCT ID
NCT06926868
Phase
PHASE2 / PHASE3
Sponsor
Bristol-Myers Squibb
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Iza-bren
  • Nab-paclitaxel
  • Paclitaxel
  • Capecitabine
  • Carboplatin
  • Gemcitabine
Locations (sample)
  • Hot Springs, Arkansas, United States|34.5037,-93.05518
  • Cerritos, California, United States|33.85835,-118.06479
  • Cerritos, California, United States|33.85835,-118.06479
  • Cerritos, California, United States|33.85835,-118.06479
  • Cerritos, California, United States|33.85835,-118.06479

Key Eligibility Criteria

  • Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER \< 1%, PgR \< 1%, HER2 IHC …
  • 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 …
  • i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC; ii) Has…

For full eligibility, visit ClinicalTrials.gov.

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