A Study of NG-350A in People with Advanced or Metastatic Epithelial Tumors

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Full Title

A Multicenter, Open-Label, Non-Randomised First in Human Study of NG-350A in Patients with Metastatic or Advanced Epithelial Tumours (FORTITUDE)

Purpose

The purpose of this study is to assess the safety of the investigational drug NG-350A in people with advanced or metastatic epithelial cancer. NG-350A is a weakened form of a virus called enadenotucirev, and it has a special gene inserted into it. The virus is weakened so it can multiply preferentially in cancer cells but not in normal cells.

The special gene in NG-350A (called a “transgene”) provides information to make a protein called anti-CD40 antibody inside cancer cells. Researchers think the anti-CD40 antibody may help the immune system attack cancer. Patients in this study will receive NG-350A 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 or metastatic epithelial cancer that continues to grow despite standard therapies.
  • At least 4 weeks must pass since the completion of prior treatments and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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 age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Danny Khalil at 646-888-4384.

Protocol

19-261

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators