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Completed

NCT Number: NCT02759250

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

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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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UZG - Universitair Ziekenhuis Gent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARGX-110

Drug

Primary outcomes

  1. Incidence and grading of AEs

    Time frame: 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 outcomes

  1. Pharmacokinetic profile of ARGX110 by Cmax

    Time frame: 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

  2. Pharmacokinetic profile of ARGX110 by AUC

    Time frame: 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

  3. Biomarkers CD70 immunohistochemistry (IHC)

    Time frame: measured at Screening, Day 42, and thereafter every 42 days until day Day 378

    Change in Measurement of concentration in tumor tissue

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 3, 2016
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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