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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
UZG - Universitair Ziekenhuis Gent
Ghent, Belgium
Incidence and grading of AEs
Change from baseline in incidence and grading of AEs according to the Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03
Time frame: measured at screening, Day 1, Day 8, Day 15, Day 42, thereafter every 42 days until Day 378
Pharmacokinetic profile of ARGX110 by Cmax
Change from baseline in Measurement of drug concentration in the blood
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
Pharmacokinetic profile of ARGX110 by AUC
Change in Measurement of drug concentration in the blood
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
Biomarkers CD70 immunohistochemistry (IHC)
Change in Measurement of concentration in tumor tissue
Time frame: measured at Screening, Day 42, and thereafter every 42 days until day Day 378
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