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Open-label Multicenter Phase 1 Study of TBI 302 as Second-Line Therapy in Patients With Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:
An Open-label, Multicenter, Phase 1 Study of TBI 302 as Second-Line Therapy in Patients With Non-resectable, Non-transplantable, Non-radiofrequency Ablation (RFA) Treatable Hepatocellular Carcinoma (HCC)

Clinical Trial Summary

Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide. TBI 302 is being developed for the treatment of inoperable HCC by intravenous infusion. The objective is to determine the safety and tolerability of TBI 3002.

Clinical Trial Description

This is an open-label, Phase 1 study to evaluate the safety, tolerability, PK, and MTD of TBI 302 in patients with non-resectable, non-transplantable HCC. Tumor response will be assessed at Week 9 (5 weeks following cessation of treatment) according to RECIST (ver 1.1) and AASLD criteria. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03908840
Study type Interventional
Source Therapure Biopharma Inc
Contact
Status Not yet recruiting
Phase Phase 1
Start date December 2019
Completion date March 2021
View Details
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