Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-30 @ 5:05 PM
Study NCT ID:
NCT05165433
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2021-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours (FORTIFY)
Sponsor:
Akamis Bio
Organization:
Study Overview
Official Title:
A Multicentre, Open-label, Non-randomized, Phase 1a/1b 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:
COMPLETED
Status Verified Date:
2025-03
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 1a/1b, 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:
False
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?: