Full TitleA Multicentre, Open-Label, Non-Randomised First in Human Study of NG-350A (Monotherapy), and NG-350A with Pembrolizumab in Patients with Metastatic or Advanced Epithelial Tumours (FORTITUDE)
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).
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.