Ignite Creation Date:
2024-05-06 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05165433
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-02
First Post:
2021-12-07
Brief Title:
Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours FORTIFY
Sponsor:
Akamis Bio
Organization:
Akamis Bio
Study Overview
Official Title:
A Multicentre Open-label Non-randomized Phase 1a1b Study of NG-350A a Tumour-selective Anti-CD40-expressing Adenoviral Vector in Combination With Pembrolizumab in Patients With Metastatic or Advanced Epithelial Tumours
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
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:
FORTIFY
Brief Summary:
This is a phase 1a1b multicentre open-label non-randomized study of NG-350A in combination with pembrolizumab in patients with metastatic or advanced epithelial tumours
Detailed Description:
Phase 1a will investigate NG-350A administration by intravenous IV infusion in combination with fixed-dose pembrolizumab in patients with metastatic or advanced tumours
Phase 1b will further investigate the efficacy and safety of the selected dose regimen in up to three of the tumour types evaluated in Phase 1a
Phase 1b will further investigate the efficacy and safety of the selected dose regimen in up to three of the tumour types evaluated in Phase 1a
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