NCT04051112

Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Ascites

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Sichuan Clover Biopharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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;

Conditions

• Malignant Ascites

Interventions

Type	Name	Description
DRUG	SCB-313	10mg group: Intraperitoneal injection single dose on Day 0, safety observation for 7 days, then 3 continuous doses on Day7, Day8, Day9, 21 days for 1 cycle

Timeline

• Start date: 2019-09-28
• Primary completion: 2021-12-24
• Completion: 2022-04-21
• First posted: 2019-08-09
• Last updated: 2022-05-06

Locations

1 site across 1 country: China