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.
Male or female of 18-75 (inclusive) years of age.
Patients with histologically and/or cytologically and/or radiologically confirmed advanced (unresectable or metastatic) hepatocellular carcinoma (HCC) that have failed any of standard treatment (including Immunotherapies and/or Tyrosine Kinase Inhibitor therapies, or Oxaliplatin-based systemic chemotherapies), recurrence, or are intolerant.
Before treatment initiation, patients must have previously completed chemotherapy, radiotherapy, interventional therapy for more than 4 weeks (except palliative radiotherapy for bone metastasis). And all treatment-related toxicities (except hair loss, pigmentation, and chemotherapy-related neurotoxicities, etc.) have recovered (≤ level 1 or baseline level).
Have at least one evaluable disease lesion based on the modified Response Evaluation Criteria in Solid Tumors (mRECIST).
Patients of central nervous system metastasis with clinical symptoms (except patients who are asymptomatic, and no disease progression confirmed by MRI diagnosis for more than 28 days).
Allergies to any ingredients or excipients in AU409.
Treatment with other anticancer therapies (including surgery, radiation therapy, chemotherapy, anti-angiogenic therapy, targeted therapy, or radiofrequency ablation therapy, etc.) or investigational therapy (except patients who stop treatment of Chinese patent medicine or Chinese herbal medicine for more than 7 days, or complete palliative radiotherapy for bone metastasis >2 weeks) within 28 days prior to the first dosing.
QTc ≥470 msec during screening period (Fridericia's equation) or with a history of congenital long QT syndrome.
Single group
AU409
DrugOral administration
Dose Limiting Toxicity
To determine the maximum tolerated dose (MTD) and the recommended phase II dose (R2PD).
Maximum Tolerated Dose
If 2 or more out of 3 or 6 patients at a dose level develop DLTs, the dose will be considered as "intolerable dose", and the preceding dose level is defined as the Maximum Tolerated Dose (MTD).
Recommended Phase 2 Dose
RP2D will be determined in accordance with occurrence of the DLTs and AEs.
Objective Response Rate
The proportion of patients whose best efficacy is CR and PR observed throughout the study from enrollment to disease progression.
Disease Control Rate
The proportion of patients whose best efficacy is CR, PR, and SD throughout the study from enrollment to disease progression.
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