Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
NCT ID:
NCT02759250
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02759250
Study Brief:
Protocol Section:
NCT02759250