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 or older
• People who have a confirmed advanced solid tumour (diagnosed through a tissue or cell sample) that has stopped responding to standard treatments, or where no standard treatments exist — in some cases, a doctor may enrol a patient who has chosen to delay remaining approved treatments, if the doctor considers this trial to be appropriate and documents that decision
• During the early (dose-escalation) part of the trial, people who have a primary liver cancer (such as hepatocellular carcinoma or bile duct cancer) or a solid tumour where most of the cancer is located in the liver, with no more than two other areas of the body affected; the specific tumour types eligible during the later (dose-expansion) part of the trial will be confirmed in a future update
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
• People who have recovered from most side effects of previous cancer treatments, with only mild effects remaining — some exceptions apply, such as ongoing mild nerve-related symptoms or managed hormone-related side effects (confirm with trial site)
• People whose previous cancer treatments (chemotherapy, radiation, targeted therapy, or immunotherapy) were completed at least 4 weeks before starting this trial's treatment, or five half-lives of the drug — whichever is shorter; palliative radiation must have been completed at least 14 days before joining
• People with an estimated life expectancy of at least 3 months
• Women who are able to become pregnant and men must agree to use effective contraception for the duration of the trial and for a set period after the last dose; men must also agree not to donate sperm during that time
• Women who are able to become pregnant are those who have not had their uterus or both ovaries removed, or who have not yet gone through natural menopause (defined as at least 12 consecutive months without a period)
• Women who are not currently pregnant and not breastfeeding, and who agree to follow the contraception guidelines during and after the trial
• People who agree to provide blood samples for drug level testing, and — for a subset of patients at higher dose levels — agree to have a liver biopsy
• People whose blood counts and organ function meet specific laboratory thresholds, including: adequate white blood cell levels, platelet counts, and haemoglobin levels; adequate kidney function; liver enzyme and bilirubin levels within acceptable ranges; and blood clotting measurements within acceptable ranges (confirm specific values with trial site)
• People with hepatocellular carcinoma who also have a condition called splenic sequestration may be eligible under slightly lower blood count thresholds (confirm with trial site)
• People with a known condition called Gilbert's syndrome may be eligible with a slightly higher bilirubin level than the standard threshold (confirm with trial site)

Who may not be able to join:

• People who have had an allergic reaction to pentamidine or to any ingredient in the trial drug AU409
• People who have received other cancer treatments — including surgery, radiation, chemotherapy, targeted therapy, or similar — or another experimental treatment within 28 days before joining (palliative radiation must have been completed at least 14 days before joining)
• People with hepatocellular carcinoma whose liver function is rated at a Child-Pugh score of B7 or higher (a measure of liver disease severity — confirm with trial site)
• People with cancer that has spread to the brain and has not been treated, or is causing symptoms; people with previously treated brain metastases may be considered if treatment was completed at least 30 days before screening, they have no symptoms, and they are not taking steroids
• People who have had certain serious heart or blood vessel events in the 6 months before starting the trial, including heart attack, severe chest pain, heart bypass surgery, significant heart failure, uncontrolled high blood pressure, serious heart rhythm problems, stroke, mini-stroke (TIA), or seizure disorder; people with atrial fibrillation (irregular heartbeat) may be considered if their heart rate is well controlled
• People whose heart's electrical activity (measured by an ECG) shows an abnormally long interval on two out of three readings (confirm specific measurement with trial site)
• People taking warfarin (a blood-thinning medication); people on other types of blood thinners such as low molecular weight heparins or Factor Xa inhibitors may be considered
• People who have had stomach or bowel surgery or conditions that affect how the body absorbs medication (such as removal of the stomach or part of the small bowel)
• People with active hepatitis B infection; people with chronic hepatitis B who are on antiviral treatment and have a low viral load may be considered (confirm with trial site)
• People with an active infection currently requiring treatment (not including hepatitis B or C as noted above), or with a known HIV infection
• People with conditions that weaken the immune system, including those on long-term steroid or immunosuppressive medication
• People with a mental health condition, substance use issue, or any other condition that the trial doctor believes would make it difficult to participate safely or meaningfully in the trial
• People who are pregnant or breastfeeding, due to potential risks to the baby
• People taking certain medications that strongly affect how the body processes drugs (known as strong CYP450 inducers or inhibitors) — these medications would need to be stopped or changed before and during the trial; in some situations, enrolment may still be considered on a case-by-case basis after discussion with the principal investigator

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