drugset / Trial / NCT03443674

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

NCT03443674 ↗

Phase 1 Completed 7 enrolled Clover Biopharmaceuticals AUS Pty
NaSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, and PK/PD of SCB-313 (recombinant human TRAIL-Trimer fusion protein) administered twice weekly for 2 weeks via IP bolus injection for the treatment of patients with peritoneal malignancies, including but not limited to peritoneal carcinomatosis, malignant ascites, pseudomyxoma peritonei, and peritoneal mesothelioma.

Timeline

Start
2018-06-18
Primary completion
2021-05-30
Completion
2021-08-26

Drugs

EvaluationDrugModalityDoseRoute
Subject SCB-313 Protein / enzyme biologic 10 mg Other
Subject SCB-313 Protein / enzyme biologic 20 mg Other
Subject SCB-313 Protein / enzyme biologic 40 mg Other
Subject SCB-313 Protein / enzyme biologic 80 mg Other
Subject SCB-313 Protein / enzyme biologic 160 mg Other

Indications