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

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: arGEN-X BVBA; argenx

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