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

NCT07310173 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-12-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Zhejiang Hisun Pharmaceutical Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-10-01
Completion
2027-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07310173 on ClinicalTrials.gov