Trials / Recruiting
RecruitingNCT06374485
Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment
A Phase I, Single-arm, Open-label, Dose-escalation, Safety and Pharmacokinetic Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- Lee's Pharmaceutical Limited · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AU409 | Oral administration |
Timeline
- Start date
- 2024-05-21
- Primary completion
- 2025-12-28
- Completion
- 2025-12-31
- First posted
- 2024-04-18
- Last updated
- 2025-08-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06374485. Inclusion in this directory is not an endorsement.