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

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)

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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