GT90001 Plus Nivolumab in Patients With Advanced Hepatocellular Carcinoma
Status:
Active, not recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
This is a 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.