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OncoMatch/Clinical Trials/NCT07310173

Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma

Is NCT07310173 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including AST-3424 and Regorafenib Tablets for hcc - hepatocellular carcinoma.

Phase 2RecruitingZhejiang Hisun Pharmaceutical Co. Ltd.NCT07310173Data as of May 2026

Treatment: AST-3424 · Regorafenib TabletsThe 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.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Biomarker criteria

Required: AKR1C3 high expression (high)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: immune checkpoint inhibitor

Lab requirements

Liver function

child-pugh class a or b liver function (score ≤ 7), with no history of hepatic encephalopathy

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