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

Sponsor
University Hospital, Grenoble
Study ID
NCT05448677
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 15, 2022
Status verified
Apr 2025
Primary completion
Mar 8, 2024
Completion
Mar 8, 2024

Study Design

Enrollment
3 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Ezurpimtrostat+Atezolizumab-Bevacizumab
  • Active Comparator: Control
    Atezolizumab-Bevacizumab

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: At 36 months ]

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