Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04830592
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-23
First Post:
2021-03-31
Brief Title:
A Study of NG-641 and Pembrolizumab in Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Akamis Bio
Organization:
Akamis Bio
Study Overview
Official Title:
A Multicentre Open-label Dose-escalating Phase Ib Study of Intravenous Dosing of NG-641 as Monotherapy or in Combination With Pembrolizumab in Patients With Surgically Resectable Squamous Cell Carcinoma of the Head and Neck
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:
MOAT
Brief Summary:
A multicentre open-label non-randomized phase Ib neoadjuvant study of intravenous NG-641 as monotherapy or in combination with pembrolizumab in patients with surgically resectable squamous cell carcinoma of the head and neck SCCHN
Detailed Description:
Part A NG-641 monotherapy Approximately 16 evaluable patients will receive three doses of IV NG-641 in Part A Patients will then proceed to planned surgical resection
Part B NG-641 and pembrolizumab Up to 20 evaluable patients will receive three doses of IV NG-641 and one dose of pembrolizumab Patients will then proceed to planned surgical resection
Part B NG-641 and pembrolizumab Up to 20 evaluable patients will receive three doses of IV NG-641 and one dose of pembrolizumab Patients will then proceed to planned surgical resection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None