Phase 1 Liver Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years old (inclusive).
• People who have been diagnosed with advanced liver cancer (hepatocellular carcinoma) that cannot be removed by surgery or has spread, confirmed by tissue sample, cell sample, or imaging, and whose cancer has not responded to standard treatments such as immunotherapy, targeted therapies (tyrosine kinase inhibitors), or oxaliplatin-based chemotherapy, or who could not tolerate those treatments.
• People who finished previous chemotherapy, radiation, or interventional treatments more than 4 weeks before joining, and whose side effects from those treatments have largely resolved (except for hair loss, skin pigmentation changes, or certain nerve-related side effects).
• People who have at least one measurable area of cancer that can be tracked using standard imaging criteria (mRECIST).
• People with a performance status score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physically demanding activity (confirm with trial site).
• People whose liver function falls within Child-Pugh class A, or a mild form of class B (score of 7 or below with no brain confusion caused by liver disease).
• People with a life expectancy of more than 12 weeks.
• People who are able to swallow and take oral medication.
• People whose recent blood test results (within 7 days before starting treatment) meet specific requirements for blood cell counts, liver function, kidney function, and blood clotting — and who have not received a blood transfusion or blood-stimulating medications in the 14 days before starting treatment (confirm with trial site for exact values).
• Women of childbearing age who have a negative pregnancy test before starting the trial, and all participants of childbearing potential who agree to use contraception throughout the study and for 6 months after the last dose of the study drug.
• People who are willing to give written informed consent to participate.

Who may not be able to join:

• People who have cancer that has spread to the brain or central nervous system and is causing symptoms (those with no symptoms and no confirmed progression on MRI for more than 28 days may still be considered).
• People with a known allergy to any ingredient in the study drug AU409.
• People who have received other cancer treatments — such as surgery, chemotherapy, radiation, targeted therapy, or similar — within 28 days before the first dose (exceptions may apply for certain bone-related palliative radiation or if certain herbal medicines were stopped more than 7 days prior).
• People with a prolonged heart electrical interval (QTc of 470 milliseconds or more on an ECG) or a personal history of a condition called congenital long QT syndrome.
• People who have had certain stomach or intestinal surgeries that could affect how the body absorbs medication, or who have ongoing conditions such as severe nausea, vomiting, peptic ulcer, inflammatory bowel disease, chronic diarrhea, or similar digestive problems.
• People who need ongoing drainage of fluid from the abdomen or chest, or who have had a portal vein shunt procedure.
• People who have experienced a hole or tear in the gastrointestinal tract, abdominal abscess, an abnormal passage between organs, bowel obstruction, liver-related brain confusion, or blood clots in major veins near the liver within the 3 months before joining.
• People who have had gastrointestinal bleeding (such as from varicose veins in the oesophagus or stomach, or active ulcers) within the 3 months before joining, or who have a clear tendency to bleed, or who are currently taking blood-thinning or clot-dissolving medications.
• People with lung disease involving inflammation of the lung tissue (interstitial lung disease or non-infectious pneumonia).
• People who have previously received a stem cell transplant or organ transplant from another person.
• People who have had major surgery (not including biopsy or needle procedures) or a significant physical injury within 28 days before starting the trial.
• People with an active infection that is affecting daily life or requires systemic treatment (such as antibiotics, antifungal or antiviral medications, steroids, or supplemental oxygen), including serious infections requiring hospitalisation.
• People with certain uncontrolled medical conditions, including moderate-to-severe heart failure, severe or unstable chest pain (angina), certain heart muscle diseases, a heart attack or heart bypass surgery within the past 6 months, uncontrolled high blood pressure, serious heart rhythm problems requiring treatment, reduced heart pumping function on echocardiogram, blood clots in deep veins or lungs within the past 2 months, stroke or mini-stroke within the past 6 months, certain eye lens conditions such as cataracts, poorly controlled diabetes, poorly controlled thyroid disease, or significant protein in the urine.
• People who are HIV positive (HIV 1 or 2 antibody positive).
• People with active hepatitis B virus (HBsAg positive with HBV DNA at or above a certain level), active hepatitis C virus (with HCV antibody and RNA above a certain level), or who test positive for both hepatitis B surface antigen and hepatitis C antibody.
• People who have had tuberculosis and have needed or are currently receiving anti-tuberculosis treatment within the past year.
• People who are pregnant or breastfeeding.
• People who have been diagnosed with another cancer within the past 5 years (exceptions may apply for certain cured skin cancers, localised prostate cancer treated with radical surgery, or early-stage breast cancer treated with radical surgery).
• People with other serious physical or mental health conditions that could increase treatment risk or affect the reliability of the trial results, including issues with alcohol, smoking addiction, or drug use that may affect participation or safety monitoring.
• People who, in the opinion of the trial investigator, are otherwise not suitable for the study.
• People who have been treated with the medication pentamidine before or during the study.

Important: Always verify eligibility with the trial site directly before applying.