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First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody) — FORTITUDE  

Metastatic Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03852511
Study type Interventional
Source PsiOxus Therapeutics Ltd
Contact
Status Completed
Phase Phase 1
Start date February 19, 2019
Completion date February 4, 2022
View Details
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