Ignite Creation Date:
2024-05-06 @ 12:48 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03852511
Status:
COMPLETED
Last Update Posted:
2022-06-24
First Post:
2019-02-11
Brief Title:
First in Human Study of NG-350A an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody
Sponsor:
Akamis Bio
Organization:
Akamis Bio
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FORTITUDE
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None