Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588038
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2020-10-07
Brief Title:
NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery
Sponsor:
Hyunseok Kang MD
Organization:
University of California San Francisco
Study Overview
Official Title:
A Window of Opportunity Trial of NT-I7 in Patients With Locally Recurrent Squamous Cell Carcinoma of Head and Neck SCCHN Undergoing Salvage Surgery
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This phase I trial evaluates the side effects of NT-I7 in treating patients with squamous cell carcinoma of head and neck that has come back recurrent who are undergoing surgery NT-I7 is an immunotherapy drug that works by helping the immune system fight tumor cells The body produces T-cells which play an important role in bodys immune response and its ability to recognize tumor cells This immunotherapy drug may boost bodys T-cells to help fight cancer and enhance bodys response to cancer
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate safety and feasibility of a single intramuscular injection of efineptakin alfa NT-I7 in patients with locally recurrent squamous cell carcinoma of head and neck SCCHN
SECONDARY OBJECTIVES
I To describe changes in absolute lymphocyte count ALC in peripheral blood after a single dose of NT-I7
II To describe changes in tumor infiltrating lymphocytes TIL in tumor microenvironment of surgical specimen after a single dose of NT-I7
III To evaluate changes in immune subsets in peripheral blood after a single dose of NT-I7 and after surgery
EXPLORATORY OBJECTIVE
I To make assessment of exploratory biomarkers for pharmacodynamic activity of NT-I7 in peripheral blood andor tumor tissue
OUTLINE
Patients receive one dose of efineptakin alfa intramuscularly IM
After completion of study treatment patients are followed up for 35 days after dose or 21 days after surgery
I To evaluate safety and feasibility of a single intramuscular injection of efineptakin alfa NT-I7 in patients with locally recurrent squamous cell carcinoma of head and neck SCCHN
SECONDARY OBJECTIVES
I To describe changes in absolute lymphocyte count ALC in peripheral blood after a single dose of NT-I7
II To describe changes in tumor infiltrating lymphocytes TIL in tumor microenvironment of surgical specimen after a single dose of NT-I7
III To evaluate changes in immune subsets in peripheral blood after a single dose of NT-I7 and after surgery
EXPLORATORY OBJECTIVE
I To make assessment of exploratory biomarkers for pharmacodynamic activity of NT-I7 in peripheral blood andor tumor tissue
OUTLINE
Patients receive one dose of efineptakin alfa intramuscularly IM
After completion of study treatment patients are followed up for 35 days after dose or 21 days after surgery
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2020-07340 | REGISTRY | CTRP Clinical Trial Reporting Program | None |