Clinical Trial

Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment

Recruiting Phase 1
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Record status
This record was last updated August 26, 2025 (before its estimated December 28, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study is a Phase I, dose-escalation study of AU409 in advanced hepatocellular carcinoma patients who failed standard treatment. A '3+3' dose-escalation design will be utilized to gradually increase the dose of AU409, aiming to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of multi-dose AU409 in patients with advanced HCC.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-04-16; most recent amendment 2025-08-19.
Trial Details
NCT Number NCT06374485
Lead Sponsor Lee's Pharmaceutical Limited
Conditions Advanced Hepatocellular Carcinoma
Enrollment 18 participants
Start Date 2024-05-21
Primary Completion 2025-12-28 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-26