Actively Recruiting
Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment
Led by Lee's Pharmaceutical Limited · Updated on 2025-08-26
18
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years inclusive
- Histologically, cytologically, or radiologically confirmed advanced (unresectable or metastatic) hepatocellular carcinoma that failed standard treatments
- Completed prior chemotherapy, radiotherapy, or interventional therapy at least 4 weeks before treatment, with recovery from related toxicities (except hair loss, pigmentation, or certain neurotoxicities)
- At least one measurable disease lesion based on modified Response Evaluation Criteria in Solid Tumors
- ECOG performance status of 0 or 1
- Child Pugh class A or some class B (score ≤7) without hepatic encephalopathy
- Life expectancy greater than 12 weeks
- Able to take oral medication
- Laboratory tests within 7 days before treatment meeting specified criteria for blood counts, liver and kidney function, coagulation, and no recent blood transfusions or growth factors
- Negative pregnancy test for premenopausal women; contraception required for males and females of childbearing potential during and for 6 months after treatment
- Provided written informed consent
You will not qualify if you...
- Symptomatic central nervous system metastases or CNS metastases with progression within 28 days
- Allergy to AU409 or its ingredients
- Other anticancer or investigational therapies within 28 days prior to dosing (with specified exceptions)
- QTc interval ≥470 msec or history of congenital long QT syndrome
- History of gastrointestinal surgeries or diseases affecting drug absorption combined with related symptoms
- Requirements for continuous drainage of serous effusions or prior portal vein shunt
- Gastrointestinal perforation, fistula, abscess, obstruction, hepatic encephalopathy, or cancer thrombus in portal vein or inferior vena cava within 3 months
- Recent gastrointestinal bleeding or bleeding tendencies, or anticoagulation/thrombolytic therapy within 3 months
- Interstitial lung disease or non-infectious pneumonia
- History of allogeneic stem cell or organ transplantation
- Major surgery or trauma within 28 days
- Infectious diseases requiring systemic treatment or affecting daily activities
- Uncontrolled serious diseases including heart failure, angina, cardiomyopathy, recent myocardial infarction or bypass surgery, uncontrolled hypertension, severe arrhythmia, low ejection fraction, recent thrombosis or embolism, stroke or transient ischemic attack, ocular lens disease, uncontrolled diabetes or thyroid disease, significant proteinuria
- HIV infection
- Active hepatitis B or C infection
- Tuberculosis requiring treatment within 1 year
- Pregnant or nursing
- Other malignancies within 5 years except certain cured in situ or localized cancers
- Severe acute, chronic, or psychiatric illnesses affecting treatment risk or compliance, including substance abuse
- Any other conditions deemed unsuitable by the investigator
- Prior or current treatment with pentamidine
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Clinical Oncology, Queen Mary Hospital
Hong Kong, China
Actively Recruiting
Research Team
C
Chi Leung Chiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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