NCT06374485
Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment
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Record History
All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗
Notable Primary completion date changed from estimate of Dec 28, 2025 to Aug 17, 2026 Show 6 more changesShow less
- Study completion date changed from estimate of Dec 31, 2025 to Sep 30, 2026
- Eligibility criteria expanded, about 38 words
- Trial completed
- Final enrollment: 11 participants (planned 18)
- Secondary endpoints: details revised at 1 of 7 entries
- Site details revised
- Minor Interventions: AU409 capsules (Drug) to AU409 (Drug)
- Study arms: 1 to 3
- Minor Primary completion date: Feb 28, 2026 to Dec 28, 2025
- Study completion date: Aug 28, 2026 to Dec 31, 2025
- Start date changed from estimate of Apr 12, 2024 to May 21, 2024
- Site contact updated
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Dose Limiting Toxicity
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
Secondary (7)
Maximum Tolerated Dose
Recommended Phase 2 Dose
Objective Response Rate
Disease Control Rate
Duration of Response
Show 2 moreShow less
Progression-free Survival
Overall Survival
Arms and interventions
AU409 120mg QDExperimental
Cohort 1
AU409 210mg QDExperimental
Cohort 2
AU409 300mg QDExperimental
Cohort 3
Drugs: AU409
Sites
1 site in 1 country
- Department of Clinical Oncology, Queen Mary HospitalHong Kong, China