drugset / Trial / NCT03869697
Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Pleural Effusions
NaSequentialOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and PK/PD of SCB-313 (recombinant human TRAIL-Trimer fusion protein) administered once via intrapleural injection (SAD) and once daily over 2 to 3 days (MAD)for the treatment of cancer patients with symptomatic malignant pleural effusions requiring drainage.
Timeline
- Start
- 2019-11-20
- Primary completion
- 2021-11-04
- Completion
- 2021-11-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SCB-313 | Protein / enzyme biologic | 5 mg | Intrathecal |
| Subject | SCB-313 | Protein / enzyme biologic | 10 mg | Intrathecal |
| Subject | SCB-313 | Protein / enzyme biologic | 20 mg | Intrathecal |
| Subject | SCB-313 | Protein / enzyme biologic | 40 mg | Intrathecal |
| Subject | SCB-313 | Protein / enzyme biologic | 80 mg | Intrathecal |