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

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argenx

Status and phase

Completed
Phase 1

Conditions

Cancer

Treatments

Drug: ARGX-110

Study type

Interventional

Funder types

Industry

Identifiers

NCT02759250
ARGX-110-1401

Details and patient eligibility

About

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).

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

11 participants in 3 patient groups

adjuvant monotherapy
Experimental group
Description:
ARGX-110 5mg/kg once every three weeks for a maximum of 18 cycles
Treatment:
Drug: ARGX-110
metastatic/recurrent monotherapy
Experimental group
Description:
ARGX-110 5mg/kg once every three weeks until disease progression
Treatment:
Drug: ARGX-110
metastatic/recurrent combination therapy
Experimental group
Description:
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.
Treatment:
Drug: ARGX-110

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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