drugset / Trial / NCT06374485

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

NCT06374485 ↗

Phase 1 Recruiting 18 enrolled Lee's Pharmaceutical Limited
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-05-21
Primary completion
2025-12-28
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject AU409 Other / unclassified 120 mg Oral
Subject AU409 Other / unclassified 210 mg Oral
Subject AU409 Other / unclassified 300 mg Oral