NCT02473731

A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Celldex Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the activity and safety of KTN3379 in head and neck cancer patients and to explore downstream molecular pathways to identify tumor response and resistance mechanisms by evaluating various biomarkers before and after treatment.

Detailed description

This is an open-label study in patients with squamous cell carcinoma of the head and neck (SCCHN) scheduled for surgery. Two cohorts of SCCHN patients, HPV negative and HPV positive, will be treated with KTN3379 to evaluate effects on ErbB3 phosphorylation and other biomarkers in tumor tissue. The KTN3379 treatment duration is within the expected window of time that elapses from initial patient evaluation by a surgeon to performance of surgery. Paired preoperative and postoperative tumor specimen analyses allow evaluation of proliferation, ErbB3 related biomarkers, pErbB3 modulation and pharmacodynamic changes in downstream molecular pathways.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	KTN3379

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-09-22
• Completion: 2016-10-10
• First posted: 2015-06-17
• Last updated: 2019-08-01

Locations

2 sites across 1 country: United States