NCT04588038

NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery

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: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Hyunseok Kang, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 body's immune response and its ability to recognize tumor cells. This immunotherapy drug may boost body's T-cells to help fight cancer and enhance body's 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, and/or 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.

Conditions

• Recurrent Head and Neck Squamous Cell Carcinoma
• Recurrent Hypopharyngeal Squamous Cell Carcinoma
• Recurrent Laryngeal Squamous Cell Carcinoma
• Recurrent Oral Cavity Squamous Cell Carcinoma
• Recurrent Oropharyngeal Squamous Cell Carcinoma
• Resectable Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Efineptakin alfa	Given via intramuscular injection

Timeline

• Start date: 2021-03-12
• Primary completion: 2025-02-03
• Completion: 2025-02-03
• First posted: 2020-10-19
• Last updated: 2025-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study