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Brief Title: First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody)
Official Title: A Multicentre, Open Label, Non-randomised First in Human Study of NG-350A (Monotherapy), and NG-350A With a Check Point Inhibitor in Patients With Metastatic or Advanced Epithelial Tumours
Study ID: NCT03852511
Brief Summary: This study will evaluate the safety, tolerability and preliminary efficacy and also pharmacokinetics, immunogenicity and other pharmacodynamic effects to elucidate the mechanism of action of NG-350A, either alone or in combination with a check point inhibitor, in patients with advanced or metastatic epithelial tumours.
Detailed Description: Phase Ia of this study is a dose escalation phase, investigating NG-350A administration by intravenous (IV) infusion, either alone or in combination with a check point inhibitor. Phase Ib of this study comprises of a Combination Dose Efficacy Expansion with NG-350A in combination with a check point inhibitor.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California, Los Angeles (UCLA), Santa Monica, California, United States
University of Colorado, Aurora, Colorado, United States
Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Name: Aung Naing, MD
Affiliation: The University of Texas MD Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR