Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-28 @ 3:04 AM
Study NCT ID:
NCT04830592
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2021-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of NG-641 and Pembrolizumab in Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Akamis Bio
Organization:
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:
COMPLETED
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:
True
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?: