Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma
Phase IIb, Randomized, Active-Controlled, Parallel-Group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AST-3424 in Patients With AKR1C3-High Expressing Advanced Hepatocellular Carcinoma Who Progressed After Systemic Therapy With Immune Checkpoint Inhibitors
Zhejiang Hisun Pharmaceutical Co. Ltd.
75 participants
Jan 1, 2026
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if drug AST-3424 works to treat AKR1C3 high expressing advanced hepatocellular carcinoma after failure of systemic therapy with immune checkpoint inhibitors. The main question it aims to answer is: Does AST-3424 prolong survival in patients with AKR1C3-high Expressing advanced Hepatocellular Carcinoma who have progressed after immune checkpoint inhibitors based therapies? Researchers will compare AST-3424 to regorafenib (current optional therapy for target patients) to see if AST-3424 works. Participants will: Receive AST-3424 infusion on Day 1 and Day 8 of each 21-day treatment cycle or take regorafenib once a day on Day 1 -Day 21 of each 28-day treatment cycle.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
AST-3424 is administered via intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle
160 mg orally, once daily for the first 21 days of each 28-day treatment cycle.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07310173