Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT04051112
Status:
COMPLETED
Last Update Posted:
2022-05-06
First Post:
2019-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Ascites
Sponsor:
Sichuan Clover Biopharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
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 Ascites
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1. The safety and tolerability of single-dose of SCB-313 will be evaluated by intraperitoneal injection;
2. The safety and tolerability of repeated-dose of SCB-313 will be evaluated by intraperitoneal injection once a day for 3 days, and the maximum tolerated dose (MTD) of SCB-313 will be determined;
2. The safety and tolerability of repeated-dose of SCB-313 will be evaluated by intraperitoneal injection once a day for 3 days, and the maximum tolerated dose (MTD) of SCB-313 will be determined;
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: