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

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02473731
Study type Interventional
Source Celldex Therapeutics
Contact
Status Completed
Phase Phase 1
Start date October 2015
Completion date October 10, 2016
View Details
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