Ignite Creation Date:
2024-05-06 @ 1:32 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04053283
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-22
First Post:
2019-08-09
Brief Title:
First in Human Study With NG-641 a Tumour Selective Transgene Expressing Adenoviral Vector
Sponsor:
Akamis Bio
Organization:
Akamis Bio
Study Overview
Official Title:
A Multicentre Open-label Non-randomised First in Human Study of NG-641 a Tumour Selective Transgene Expressing Adenoviral Vector in Patients With Metastatic or Advanced Epithelial Tumours STAR
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
STAR
Brief Summary:
To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours
Detailed Description:
To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours
The Phase 1a part of the study is a dose-escalation and dose-optimization phase investigating NG-641 administration by intravenous IV infusion in a range of tumour types
The Phase 1b part of the study will investigate the selected optimized multicycle dosing regimen as a monotherapy in up to three cohorts of patients with specific tumour types Dose Expansion Cohorts A B and C
The Phase 1a part of the study is a dose-escalation and dose-optimization phase investigating NG-641 administration by intravenous IV infusion in a range of tumour types
The Phase 1b part of the study will investigate the selected optimized multicycle dosing regimen as a monotherapy in up to three cohorts of patients with specific tumour types Dose Expansion Cohorts A B and C
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