drugset / Trial / NCT03468751
Phase 1 Study of HLX10, a Monoclonal Antibody Targeting Programmed Death-1 (PD-1) in Patients With Advanced Solid Tumors
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of humanized anti-PD-1 monoclonal antibody, HLX10, in patients with advanced or metastatic tumors refractory to standard therapy. This study will also evaluate the pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumor effect of HLX10 and explore the potential prognostic and predictive biomarkers.
Timeline
- Start
- 2018-02-14
- Primary completion
- 2020-06-30
- Completion
- 2020-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Serplulimab | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | Serplulimab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Serplulimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Serplulimab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Serplulimab | Monoclonal antibody | 200 mg | Intravenous |