RecruitingPhase 2NCT07310173

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


Sponsor

Zhejiang Hisun Pharmaceutical Co. Ltd.

Enrollment

75 participants

Start Date

Jan 1, 2026

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new drug called AST-3424 in people with advanced liver cancer (hepatocellular carcinoma, or HCC) whose tumours have a high level of an enzyme called AKR1C3. The drug is designed to target cancers with this specific enzyme. It's for patients whose cancer has continued to grow after previous immunotherapy treatments. **You may be eligible if...** - You have confirmed advanced liver cancer - Your cancer progressed during or after treatment with immune checkpoint inhibitors (a type of immunotherapy) - Your cancer is not suitable for surgery or local treatments - Your liver function is reasonably preserved (Child-Pugh A or B) - Your tumour tests show high AKR1C3 enzyme levels **You may NOT be eligible if...** - Your liver function is severely impaired - You have not received prior immunotherapy - You have certain other medical conditions preventing participation Talk to your doctor to see if this trial is right for you.

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.

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Interventions

DRUGAST-3424

AST-3424 is administered via intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle

DRUGRegorafenib Tablets

160 mg orally, once daily for the first 21 days of each 28-day treatment cycle.


Locations(1)

Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, China

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NCT07310173


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