NCT05178043

GT90001 Plus Nivolumab in Patients With Advanced Hepatocellular Carcinoma

A Phase II Study to Evaluate the Efficacy and Safety of GT90001 in Combination With Nivolumab as a Second-line Treatment in Subjects With Advanced Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Suzhou Kintor Pharmaceutical Inc, · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma
• HCC

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab 240mg to be administered as an intravenous (IV) infusion every 2 weeks (Q2W).
DRUG	GT90001	GT90001 7mg/kg to be administered as an intravenous infusion every 2 weeks (Q2W) after Nivolumab infusion.

Timeline

• Start date: 2021-08-01
• Primary completion: 2025-04-01
• Completion: 2025-12-01
• First posted: 2022-01-05
• Last updated: 2024-02-22

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study