Cancer
Conditions
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).
Interventions
DRUGARGX-110
Sponsors
argenx
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years. * Written informed consent prior to any study-related procedure * Willing and able to comply with protocol-specified procedures and scheduled evaluations * Pathological diagnosis of nasopharyngeal carcinoma (NPC) * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1or 2 * Absolute neutrophil count (ANC) \> 0.5 x 109/L * Haemoglobin \> 80 g/L * Platelet count ≥ 50 x 109/L * Total bilirubin ≤ 2 x the upper limit of normal (ULN) * Alanine transaminase (ALT) ≤ 5 x ULN * Serum creatinine ≤ 2 x ULN
Exclusion criteria
* History or clinical evidence of neoplastic central nervous system (CNS) involvement. Note: Irradiated brain metastases that have been stable for \> 1 month and do not require systemic glucocorticoid administration are allowed * Major surgery within 4 weeks of ARGX-110 first dose administration * Unresolved grade 3 or 4 toxicity from prior therapy (except mucositis from local radiation therapy). * Active, untreated viral, bacterial, or systemic fungal infection * Childbearing potential unless using an adequate measure of contraception * Pregnancy or lactation. History of hypersensitivity to recombinant proteins * Any clinical finding, including psychiatric and behavioural problems, which, in the opinion of the Investigator, precludes the patient from safely participating in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and grading of AEs | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic profile of ARGX110 by Cmax | 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 | 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) | measured at Screening, Day 42, and thereafter every 42 days until day Day 378 | Change in Measurement of concentration in tumor tissue |
Countries
Belgium
Outcome results
None listed