RecruitingPhase 1NCT06374485

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


Sponsor

Lee's Pharmaceutical Limited

Enrollment

18 participants

Start Date

May 21, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral drug called AU409 in people with advanced liver cancer (hepatocellular carcinoma) who have already tried and failed standard treatments, including immunotherapy and targeted drugs. **You may be eligible if...** - You are between 18 and 75 years old with confirmed advanced or metastatic liver cancer - You have already tried standard treatments (including immunotherapy and/or targeted therapies or chemotherapy) and your cancer has progressed - At least 4 weeks have passed since your last treatment - You have at least one measurable tumor lesion **You may NOT be eligible if...** - You have not yet tried available standard treatments - Your organ function does not meet minimum requirements - You have uncontrolled infections, uncontrolled bleeding, or significant heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAU409

Oral administration


Locations(1)

Department of Clinical Oncology, Queen Mary Hospital

Hong Kong, China

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NCT06374485


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