Clinical Trial: A Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Pilot, Phase Ib Feasibility Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)

Brief Summary: To characterize the safety profile of ARGX-110 administered as mono- or combination therapy to patients with NPC at various stages of its natural history (adjuvant vs. metastatic).

Detailed Summary:
Sponsor: arGEN-X BVBA

Current Primary Outcome: Incidence and grading of AEs [ Time Frame: measured at screening, Day 1, Day 8, Day 15, Day 42, thereafter every 42 days until Day 378 ]

Change from baseline in incidence and grading of AEs according to the Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacokinetic profile of ARGX110 by Cmax [ Time Frame: measured at Day 1 pre and post dose, Day 8, Day 15, Day 42 pre and post dose and thereafter every 42 days until Day 378 ]
    Change from baseline in Measurement of drug concentration in the blood
  • Pharmacokinetic profile of ARGX110 by AUC [ Time Frame: measured at Day 1 pre and post dose, Day 8, Day 15, Day 42 pre and post dose and thereafter every 42 days until Day 378 ]
    Change in Measurement of drug concentration in the blood
  • Biomarkers CD70 immunohistochemistry (IHC) [ Time Frame: measured at Screening, Day 42, and thereafter every 42 days until day Day 378 ]
    Change in Measurement of concentration in tumor tissue


Original Secondary Outcome: Same as current

Information By: arGEN-X BVBA

Dates:
Date Received: April 22, 2016
Date Started: February 2015
Date Completion: July 2017
Last Updated: April 20, 2017
Last Verified: April 2017