drugset / Trial / NCT06374485
Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AU409 | Other / unclassified | 120 mg | Oral |
| Subject | AU409 | Other / unclassified | 210 mg | Oral |
| Subject | AU409 | Other / unclassified | 300 mg | Oral |