A Phase II Study of AL101 in Patients with Advanced or Recurrent Adenoid Cystic Carcinoma with Notch Mutations

Full Title

Phase 2, Open-Label, Single-Arm, Multi-Center Study of AL101 in Patients with Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

Purpose

Adenoid cystic carcinoma (ACC) is a rare form of head and neck cancer. In this study, researchers are evaluating the safety and effectiveness of the investigational drug AL101 in patients with advanced recurrent or persistent ACC that contains mutations in the Notch gene family. These genes are present in normal cells, but mutations in Notch can cause cells to become cancerous and form tumors.

AL101 works by interfering with activated Notch. The premise of this clinical trial is that blocking Notch activation will stop the uncontrolled growth of cancer cells. 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 advanced recurrent or persistent ACC that cannot be cured with standard therapies and has a Notch mutation.
  • Patients may not have received more than three prior regimens of treatment.
  • Patients should recover from the serious side effects of treatment before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alan Ho at 646-888-4235.

Protocol

19-033

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators