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 who are willing and able to give informed consent and follow the study requirements for the whole duration of the trial.
• People who are 18 years of age or older at the time of signing the consent form.
• People who have been diagnosed (confirmed by tissue testing) with a locally advanced or metastatic solid tumour that can or cannot be measured on scans.
• People whose general physical functioning is rated at a level where they are fully active, have some limits on strenuous activity, or are up and about for more than half of waking hours (confirm with trial site for exact rating).
• People whose blood counts meet the minimum levels required for white blood cells, platelets, and haemoglobin — with medical support such as transfusions or growth factors allowed to reach these levels.
• People whose kidneys are functioning at or above a minimum level, as measured by a standard calculation using age, weight, and blood test results (confirm with trial site).
• People whose fasting blood fat levels (triglycerides and cholesterol) are below specified limits.
• People who are not pregnant and not breastfeeding, and who agree to use highly effective contraception — with a second form of birth control required — from 28 days before the first dose until 3 months after the last dose, and who have a negative pregnancy test at the start of the study.
• Male participants who agree to use a condom during sexual contact with a pregnant person or someone who could become pregnant, throughout the study and for 3 months after the last dose, with a second form of birth control also required.
• People who have waited at least 4 weeks since major surgery, radiation therapy, or previous cancer treatment (or at least 5 half-lives for certain targeted medicines), and who have sufficiently recovered from side effects of prior treatment.
• People with normal liver function, based on specific blood test results being within normal ranges (for one group in the study).
• People with moderate liver impairment, based on specific blood test results falling within a defined range (for a separate group in the study).

Who may not be able to join:

• People who have received treatment with a type of drug called an mTOR inhibitor within 4 weeks before the first dose.
• People with cancer that has spread to the membranes around the brain or spinal cord, or who have untreated or unstable brain metastases — though people with stable, symptom-free brain metastases who do not need high-dose steroids or urgent radiation may still be considered.
• People with serious, uncontrolled heart conditions, including unstable chest pain, severe heart failure, a heart attack within the past 6 months, or uncontrolled irregular heart rhythm.
• People with severely reduced lung function before joining the study, based on breathing test results falling below specified thresholds or blood oxygen levels being too low at rest.
• People with other serious medical conditions that are not well controlled and could be made worse by the study treatment.
• People with uncontrolled high blood pressure (blood pressure at or above 160/100 mmHg).
• People with a history of a lung condition called interstitial lung disease, pneumonitis, or high blood pressure in the lungs.
• People with a known HIV infection.
• People with active Hepatitis B or Hepatitis C where the virus is still detectable in the blood.
• People with a serious active infection (rated as severe or above) that requires antibiotic treatment given through a drip.
• People who have taken high-dose steroid tablets or injections within 2 weeks before the first dose — though inhaled, nasal, joint, or skin-applied steroids are allowed.
• People with a history of a liver condition called Gilbert's disease.
• People where, in the treating doctor's judgement, participation would pose an unacceptable risk or make it unlikely the person could fully follow the study procedures.
• People with moderate liver impairment who have had a flare-up of liver disease symptoms (such as abdominal pain, nausea, vomiting, or fever) in the 2 weeks before the first dose.
• People with moderate liver impairment who have a build-up of fluid in the abdomen that is clinically obvious and severe.
• People with moderate liver impairment who have had signs of acute viral hepatitis within 1 month before the first dose.
• People with moderate liver impairment who show signs of a serious combined kidney-liver failure condition (confirm with trial site).
• People with moderate liver impairment who have a specific internal shunt procedure in the liver called a transjugular intrahepatic portosystemic shunt.
• People with moderate liver impairment who have active stage 3 or 4 brain function decline related to liver disease.

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