Clinical trial · Interventional
A Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)
A Pilot, Phase Ib Feasibility Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)
NCT02759250CI-TRIAL-00034206completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARGX-110 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- adjuvant monotherapy
- description
- ARGX-110 5mg/kg once every three weeks for a maximum of 18 cycles
- interventionNames
- Drug: ARGX-110
- type
- EXPERIMENTAL
- label
- metastatic/recurrent monotherapy
- description
- ARGX-110 5mg/kg once every three weeks until disease progression
- interventionNames
- Drug: ARGX-110
- type
- EXPERIMENTAL
- label
- metastatic/recurrent combination therapy
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.