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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adjuvant monotherapy | Experimental | ARGX-110 5mg/kg once every three weeks for a maximum of 18 cycles |
|
| metastatic/recurrent monotherapy | Experimental | ARGX-110 5mg/kg once every three weeks until disease progression |
|
| metastatic/recurrent combination therapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARGX-110 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | measured at screening, Day 1, Day 8, Day 15, Day 42, thereafter every 42 days until Day 378 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of ARGX110 by Cmax | Change from baseline in Measurement of drug concentration in the blood | 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie Rottey, MD | UZG - Universitair Ziekenhuis Gent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZG - Universitair Ziekenhuis Gent | Ghent | Belgium |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Change in Measurement of drug concentration in the blood |
| 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 | measured at Screening, Day 42, and thereafter every 42 days until day Day 378 |