A Phase II Study of AL101 in People with Triple-Negative Breast Cancer with a Notch Mutation

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Full Title

TENACITY: A Phase 2, Multicenter, Open-label, Single-arm Study of AL101 Monotherapy in Patients with Notch-activated Triple Negative Breast Cancer

Purpose

Notch genes play a key role in the normal development of cells and tissues. However, when there is a mutation in a Notch gene and it becomes too active (“Notch-activated”), the mutated gene can cause cells to behave differently and form cancer. AL101 is an investigational drug designed to limit the activity of mutated Notch genes. When mutated Notch genes are less active, cancer cells may stop growing or die.

In this study, researchers are assessing the safety and effectiveness of AL101 in patients with recurrent or metastatic triple-negative breast cancer that contains mutated Notch. AL101 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have recurrent or metastatic Notch-activated triple-negative breast cancer.
  • Patients may have had up to three prior regimens of therapy for metastatic disease.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Tiffany A. Traina at 646-888-5209.

Protocol

21-102

Phase

II

Investigator

Co-Investigators