NCT05448677

Ezurpimtrostat Autophagy Inhibitor in Association With Atezolizumab-Bevacizumab in First Line Treatment of Unresectable Hepatocellular Carcinoma

Ezurpimtrostat Autophagy Inhibitor in Association With Atezolizumab-Bevacizumab in First Line Treatment of Unresectable Hepatocellular Carcinoma, a Phase 2b Randomized Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will assess the efficacy of Ezurpimtrostat in association with standard of care (Atezolizumab-Bevacizumab), compared to standard of care alone, as first line treatment in patients with unresectable hepatocellular carcinoma.The study drug which is tested is the Ezurpimtrostat in association with Atezolizumab-Bevacizumab to allow a better tumor response as well as better survival outcomes with an acceptable safety.

Detailed description

The study is a multicentric, prospective, comparative, randomized, open-label phase 2b trial. This study will enroll 187 to 196 patients and consists of 2 parts: Safety Lead-in Phase and Expansion Phase. Initially, 3 to 12 patients will be enrolled into a Safety Lead-in Phase based on a 3 + 3 design, with the possibility of dose de-escalation, to confirm the recommended dose of Ezurpimtrostat.The randomized Expansion Phase will start after completion of Safety Lead-in Phase at the confirmed dose and will include 184 patients. Patients will be randomly assigned between experimental arm (Ezurpimtrostat + Atezolizumab-Bevacizumab) and control arm (Atezolizumab-Bevacizumab) according to a 1:1 repartition.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Ezurpimtrostat	Patients in the experimental arm will be instructed to take their assigned oral dose every day.
DRUG	Atezolizumab	Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-days cycle
DRUG	Bevacizumab	Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.

Timeline

• Start date: 2022-12-15
• Primary completion: 2024-03-08
• Completion: 2024-03-08
• First posted: 2022-07-07
• Last updated: 2025-04-20

Locations

1 site across 1 country: France