A Phase 1 interventional study of ARGX-110 in Cancer, sponsored by argenx. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-08.
Sponsored by argenx · Phase 1, Interventional, and Treatment
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).
816 studies on the registry are indexed under Nasopharyngeal Carcinoma; 282 are open to participants now.
This study's enrollment of 11 is below the median of 84 across 668 interventional studies indexed under Nasopharyngeal Carcinoma.
Browse Nasopharyngeal Carcinoma studies →argenx is the lead sponsor of 87 studies on the registry; 33 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 16 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
ARGX-110 5mg/kg once every three weeks for a maximum of 18 cycles
Drug: ARGX-110
ARGX-110 5mg/kg once every three weeks until disease progression
Drug: ARGX-110
ARGX-110 5mg/kg once every three weeks plus chemotherapy until disease progression. The choice of the chemotherapy agents is limited to: cisplatin, carboplatin, 5-fluorouracil, gemcitabine and paclitaxel.
Drug: ARGX-110
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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