GT90001 Plus Nivolumab in Patients With Advanced Hepatocellular Carcinoma

Status Active, not recruiting

Clinical Trial Summary

This is a global phase II, open label study in the subjects with Advanced Hepatocellular Carcinoma (aHCC) who were intolerant or had progressed after or intolerant to first-line Immune Checkpoint Inhibitors (ICI) such as Atezolizumab plus Bevacizumab, or ICI plus Tyrosine Kinase Inhibitor (TKI). Based on published and first-hand experience with the safety and tolerability of both GT90001 and Nivolumab, the proposed dose is GT90001 7 mg/kg in combination with Nivolumab 240 mg, infusion every two weeks. This study will enroll a total of 105 subjects to receive combinational therapy of Nivolumab and GT90001. • Nivolumab 240 mg will first be administered by intravenous infusion over 30 minutes, then 30 minutes later, give intravenous infusion of GT90001 7.0 mg/kg over 60 min, once every two weeks.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05178043
Study type	Interventional
Source	Suzhou Kintor Pharmaceutical Inc,
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	August 1, 2021
Completion date	December 1, 2025

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