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Advanced Hepatocellular CarcinomaPhase 1NCT06374485

Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment

A Phase 1 study testing AU409 in people with Advanced Hepatocellular Carcinoma, run by Lee's Pharmaceutical Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Hepatocellular Carcinoma
What is being tested?
AU409
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteChina
Study dates
21 May 2024to 30 Sep 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • ECOG score of 0 or 1.
  • Patients with Child Pugh class A or some class B (≤7 and no hepatic encephalopathy).
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  • Have a life expectancy of >12 weeks.
  • Able to be orally administered.
  • Laboratory examinations must meet the following criteria within 7 days before treatment initiation:
  • Absolute neutrophil count（ANC）≥1.5 × 109/L，platelets（PLT） count ≥75 × 109/L，hemoglobin（HGB）≥90 g/L，and patients are not allowed to receive blood transfusion or other haematopoietic growth factors within 14 days before treatment initiation.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be ≤5.0×upper limit of normal (ULN).
  • Total bilirubin (TBIL) ≤1.5×ULN.
  • Ablumin (ALB) ≥28g/L.
  • Serum creatinine (CRE) ≤1.0×ULN, creatinine clearance rate (CCR) ≥60 mL/min (Cockcroft-Gault equation).
  • International normalized ratio（INR）≤1.5，prothrombin time (PT) ≤1.5×ULN.
  • Have a negative serum pregnancy test for premenopausal women (postmenopausal women who have been menopausal for at least 12 months are considered as infertile). For male patients (including male patients' female spouses of child-bearing potential) and female patients of child-bearing potential must be contraceptive throughout the study and within the 6 months following the last dose of AU409.
  • Patients voluntarily give written informed consent form (ICF).

Who cannot join

  • 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.
  • Patients with history of gastrointestinal surgery that may change the absorption and activity of drugs in their body (such as total gastrectomy, small bowel resection, external bile shunt, etc.) in combination with refractory hiccups, nausea, vomiting, and other diseases that affect drug absorption (such as peptic ulcer, inflammatory bowel disease, lactose intolerance, malabsorption syndrome or chronic diarrhea, etc.).
  • Patients who require serous effusion for continuous drainage or drug infusion (such as ascites, pleural effusion, etc.), or have undergone portal vein shunt.
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  • Patients with gastrointestinal perforation and/or fistula, abdominal abscess, visceral fistula, intestinal obstruction, hepatic encephalopathy, portal vein and inferior vena cava cancer thrombus within 3 months prior to the treatment initiation.
  • Patients have gastrointestinal bleeding (including esophageal or gastric varices, local active ulcer lesions, etc.), or have a clear bleeding tendency, or are receiving anticoagulation/thrombolytic therapy within 3 months before treatment initiation. Positive result of occult blood needs to identifythe causes.
  • Patients with interstitial lung disease, non-infectious pneumonia.
  • History of allogeneic stem cell transplantation or organ transplantation.
  • Patients who receive major surgery (except biopsy and puncture) or with major trauma within 28 days before treatment initiation.
  • Patients with infectious diseases that affect daily activities or require systemic treatment (such as the use of hormones, antibiotics, antifungal drugs, antiviral drugs, and oxygen inhalation), including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.
  • Uncontrolled diseases, including a) New York Heart Association (NYHA) Class II or higher heart failure, b) Severe/unstable angina pectoris, c) Primary cardiomyopathy, d) Myocardial infarction or coronary/peripheral artery bypass surgery occurred within 6 months before treatment initiation, e) Uncontrollable high blood pressure, f) Severe arrhythmia requiring medication or intervention, g) Echocardiographic left ventricular ejection fraction <50% during the screening period, h) Deep vein thrombosis/arterial thrombosis /Pulmonary vein embolism occurred within 2 months before treatment initiation, i) Cerebrovascular accident or transient ischemic attack occurred within 6 months before treatment initiation, j) Ocular lens disease (such as cataract), k) Diabetes that has not been effectively controlled, l) Thyroid diseases that have not been effectively controlled, m) Urine protein≥2+ and quantity of 24-hour urine protein ≥1.0g.
  • Human immunodeficiency virus infection (HIV 1/2 antibody positive).
  • HBV infection (HBsAg positive and HBV DNA ≥2000 IU/mL); Hepatitis C virus (HCV) antibody is positive and HCV RNA>103 copies/ml; HBsAg and HCV antibodies are both positive.
  • Patients with tuberculosis (TB) who need to receive/are receiving anti-TB treatment within 1 year before treatment initiation.
  • Pregnant or nursing；
  • Patients complicated with other malignant tumors within 5 years before treatment initiation, except various in situ tumors, skin basal cell carcinoma or squamous cell carcinoma that have been cured in the past, local prostate cancer receiving radical operation, and in situ breast ductal carcinoma receiving radical operation.
  • Patients with other severe, acute, chronic, or psychiatric illnesses that may increase the risk of treatment or may interfere with interpretation of the trial results. And patients with alcoholism, smoking addiction, drug abuse, and other circumstances that are not conductive to the treatment or explain adverse events, thereby contributing to decrease study compliance.
  • Other conditions that are not suitable for participating in the study in the opinion of investigator.
  • Patients who were treated with pentamidine prior to treatment initiation or during the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Clinical Oncology, Queen Mary Hospital

    Hong Kong

Other trials in China

About this study

Official title: 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

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.

Being tested
AU409

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AU409Drug

    Oral administration

Study groups in NCT06374485
Study groupRoleWhat they receive
AU409 120mg QDExperimentalCohort 1
Receives: Drug: AU409
AU409 210mg QDExperimentalCohort 2
Receives: Drug: AU409
AU409 300mg QDExperimentalCohort 3
Receives: Drug: AU409

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity

    To determine the maximum tolerated dose (MTD) and the recommended phase II dose (R2PD).

    Measured: At the end of Cycle 1 (each cycle is 28 days)

Secondary outcomes (7)

  1. 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).

    Measured: Through study completion, an average of 2 years

  2. Recommended Phase 2 Dose

    RP2D will be determined in accordance with occurrence of the DLTs and AEs.

    Measured: Through study completion, an average of 2 years

  3. Objective Response Rate

    The proportion of patients whose best efficacy is CR and PR observed throughout the study from enrollment to disease progression.

    Measured: Through study completion, an average of 2 years

  4. Disease Control Rate

    The proportion of patients whose best efficacy is CR, PR, and SD throughout the study from enrollment to disease progression.

    Measured: Through study completion, an average of 2 years

  5. Duration of Response

    The time from the first tumor evaluation as CR or PR to the first evaluation as PD or death from any cause during the study.

    Measured: Through study completion, an average of 2 years

  6. Progression-free Survival

    The time from enrollment until the disease progression or death from any cause.

    Measured: Through study completion, an average of 2 years

  7. Overall Survival

    The time from enrollment to death from any cause.

    Measured: Through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2024
  2. Study start21 May 2024
  3. Primary completion17 Aug 2026
  4. Study completion30 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06374485
Sponsor's protocol ID
AU409-LEES-2021-03
Status last verified
Apr 2025
First submitted
11 Mar 2024
Last updated
3 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AU409 in people with Advanced Hepatocellular Carcinoma, run by Lee's Pharmaceutical Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (time frame: At the end of Cycle 1 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06374485.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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