NCT07310173

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HCC - Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	AST-3424	AST-3424 is administered via intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle
DRUG	Regorafenib Tablets	160 mg orally, once daily for the first 21 days of each 28-day treatment cycle.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

1 site across 1 country: China