Phase 1 Liver Cancer Trial, Recruiting

Written by an AI model from the 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 who weigh at least 50 kg and have a Body Mass Index (BMI) between 18 and 40.
• People who are willing to use contraception in line with local guidelines for clinical trial participants (or whose partners will do so).
• People who have veins that are suitable for blood draws or having a drip inserted.
• People who have not smoked or used nicotine products for at least 3 months before the screening visit.
• People with liver impairment that has been confirmed by supporting medical documents and classified by the study doctor as "Child Pugh class B" — a specific measure of liver disease severity (confirm with trial site).
• People whose liver impairment falls into the "moderate" category based on specific blood test results, as defined by a medical classification system called NCI-ODWG (confirm with trial site).
• People whose liver impairment is stable and not getting worse.
• People with normal liver function who have specific blood test results within acceptable ranges for liver and kidney markers (confirm with trial site for exact values).

Who may not be able to join:

• People with serious or poorly controlled health conditions, such as uncontrolled high blood pressure, a significant aneurysm, a kidney transplant, or active bleeding disorders.
• People with ongoing severe nausea or vomiting, chronic gut conditions, an inability to swallow tablets, or who have had significant bowel surgery that could affect how the body processes medication.
• People with a history of cancer, unless it was treated with the intent to cure, has shown no signs of returning for at least 2 years, and carries a low risk of coming back — with some exceptions for certain skin cancers and treated in-situ conditions.
• People with an active tuberculosis infection.
• People with a known HIV infection, active hepatitis B or C infection, or certain positive blood test results for hepatitis B or C.
• People whose blood sugar control is significantly abnormal, based on a specific blood test result (HbA1c of 8% or above).
• People with moderate or severe kidney dysfunction, based on a kidney function calculation using a blood test result (confirm with trial site for exact values).
• People whose liver function is unstable or declining quickly.
• People who have liver cancer (hepatocellular carcinoma) or acute liver disease caused by an infection or medication.
• People with severe high blood pressure in the liver's blood vessels, or who have had certain surgical procedures to redirect blood flow around the liver.
• People whose liver impairment is caused by a blockage in the bile ducts or by something other than liver tissue disease.
• People with a significant level of hepatic encephalopathy — a condition where the liver is not removing toxins properly, causing brain function problems — rated at grade 3 or above.
• People with severe fluid build-up in the abdomen (ascites).
• People who have had bleeding from swollen veins in the oesophagus (food pipe) within the past 2 months, unless those veins have been treated with a banding procedure.
• People who have previously had a liver transplant.

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