Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508606
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
AK117 Anti-CD47 Anti-EGFR for RM HNSCC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Study of AK117 Anti-CD47 Combined With Anti-EGFR in the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The administration of first-line pembrolizumab monotherapy or combined chemotherapy has been shown to improve survival among patients with recurrent or metastatic head and neck squamous cell carcinoma RM HNSCC However over 80 of the patients still experience disease progression within a year Upon progression treatment options are notably constrained typically comprising methotrexate docetaxel and cetuximab The median progression-free survivaland overall survival following chemotherapy targeted therapy or their combination are dismally low ranging from 2-3 months and 6-8 months respectively The clinical trials CheckMate 141 and KEYNOTE 040 have led to the approval of Nivolumab and Pembrolizumab as second-line treatments for RM HNSCC Nevertheless the response rates to immune monotherapy are limited ranging from 10 to 35 Even after receiving standard second-line immunotherapy over 80 of patients encounter disease progression within 6 months and more than 60 succumb to the disease within a year Therefore there is a dearth of a standardized treatment for RM HNSCC after the failure of first- or second-line PD-1 L1 inhibitors andor platinum-based therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None