drugset / Trial / NCT03316144
Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Toripalimab for Patients With Recurrent Malignant Lymphoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary objective is to assess the safety and tolerability of JS-001 in subjects with recurrent malignant lymphoma, and to evaluate its preliminary efficacy. The secondary objectives are to: 1) characterize the single-dose and multi-dose pharmacokinetic (PK) profile of JS-001, 2) characterize the immunogenicity of JS-001; 3) assess the dose-efficacy relationship of JS-001 single agent, and 4) preliminarily evaluate biomarkers associated with the efficacy of JS-001.
Timeline
- Start
- 2017-07-12
- Primary completion
- 2018-09-15
- Completion
- 2019-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Toripalimab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 10 mg/kg | Intravenous |