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

Study Overview
=================
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).

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

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: ARGX-110


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adjuvant monotherapy<br>ARGX-110 5mg/kg once every three weeks for a maximum of 18 cycles | Drug: ARGX-110<br> <br> |
| Experimental: metastatic/recurrent monotherapy<br>ARGX-110 5mg/kg once every three weeks until disease progression | Drug: ARGX-110<br> <br> |
| Experimental: metastatic/recurrent combination therapy<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |