Trials / Completed
CompletedNCT03869697
Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Pleural Effusions
A Phase I Study Evaluating the Safety, Tolerability, Efficacy, and Pharmacokinetics of SCB-313, a Fully-Human TRAIL-Trimer Fusion Protein, for the Treatment of Malignant Pleural Effusions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Clover Biopharmaceuticals AUS Pty · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SCB-313 | 5 mg or 20 mg lyophilized powder in a single-use glass vial |
Timeline
- Start date
- 2019-11-20
- Primary completion
- 2021-11-04
- Completion
- 2021-11-23
- First posted
- 2019-03-11
- Last updated
- 2022-02-02
Locations
4 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT03869697. Inclusion in this directory is not an endorsement.