drugset / Trial / NCT04097769
The Safety, Tolerability, and Initial Efficacy of HX009 in Patients With Advanced Malignancies
NaSingle-groupOpen-labelTreatment
Summary
This is a first-in-human, multicenter, open-label, multiple-dose Phase I study to investigate the safety, tolerability, and initial efficacy of HX009 in subjects with advanced malignant tumors. The study will consist of a dose-escalation and dose-finding component to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and to evaluate the preliminary antitumor activity of HX009.
Timeline
- Start
- 2019-06-12
- Primary completion
- 2021-03-18
- Completion
- 2022-09-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HX009 | Protein / enzyme biologic | 0.1 mg/kg | Intravenous |
| Subject | HX009 | Protein / enzyme biologic | 0.3 mg/kg | Intravenous |
| Subject | HX009 | Protein / enzyme biologic | 1 mg/kg | Intravenous |
| Subject | HX009 | Protein / enzyme biologic | 2 mg/kg | Intravenous |
| Subject | HX009 | Protein / enzyme biologic | 3 mg/kg | Intravenous |
| Subject | HX009 | Protein / enzyme biologic | 5 mg/kg | Intravenous |
| Subject | HX009 | Protein / enzyme biologic | 7.5 mg/kg | Intravenous |