Lee’s Pharmaceutical Holdings Limited ((HK:0950)) announced an update on their ongoing clinical study.
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Lee’s Pharmaceutical Holdings Limited is conducting a clinical study titled ‘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.’ The study aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of AU409 in patients with advanced hepatocellular carcinoma who have not responded to standard treatments.
The intervention being tested is AU409, an experimental drug administered orally. The study involves three cohorts with different dosages: 120mg, 210mg, and 300mg, to determine the optimal dose for further research.
This is an interventional study with a single-group assignment. There is no masking, and the primary purpose is treatment. The study uses a ‘3+3’ dose-escalation design to gradually increase the dosage of AU409.
The study began on March 11, 2024, and the latest update was on August 19, 2025. These dates are crucial as they indicate the study’s progress and the timeline for potential results.
The study’s progress could influence Lee’s Pharmaceutical’s stock performance and investor sentiment, especially if the results show promising efficacy. It is also relevant in the context of the competitive landscape of hepatocellular carcinoma treatments, where advancements can significantly impact market positioning.
The study is currently ongoing, with further details available on the ClinicalTrials portal.