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:

• Adults between 18 and 75 years old (exact age range may vary depending on local rules).
• For the dose-finding phase of the trial: people with advanced solid tumours (confirmed by tissue or cell testing) that have grown or spread despite standard treatment, or where no standard treatment exists. People with advanced liver cancer in this phase must also have a specific disease stage (BCLC B or C) and a liver function score of 5–6 (Child-Pugh scale), and must be able to provide a tissue sample for a specific protein test (FGF19).
• For the expansion phase of the trial: people with confirmed advanced liver cancer (BCLC stage B or C) whose cancer has progressed on, could not tolerate, or had no access to first-line treatment under local guidelines, and who are not suitable for other standard liver cancer treatments. These patients must test positive for a specific protein (FGF19 overexpression), have at least one measurable tumour, and have a liver function score of 5–7 (Child-Pugh scale) without certain complications such as brain confusion caused by liver disease or significant fluid build-up in the abdomen.
• People who are reasonably active and able to care for themselves (confirm with trial site for the specific activity scale score required).
• People with a life expectancy of at least 3 months.
• People whose blood counts and organ function (including liver and kidneys) fall within acceptable ranges on blood tests taken within 14 days before the first dose, without recent blood transfusions or certain medications.
• People with hepatitis B (HBV) infection who are following local medical guidelines and have the virus adequately controlled with antiviral treatment before joining.
• People who are not surgically sterilised and could become pregnant or father a child must agree to use effective contraception during the trial and for up to 6 months after the last dose. Women who could become pregnant must not be breastfeeding and must have a negative pregnancy test within 7 days before the first dose.
• People who are willing and able to understand, sign, and follow the requirements of the trial as described in the consent form.

Who may not be able to join:

• People with a known allergy or sensitivity to any ingredient in the study drug.
• People who have previously been treated with a type of drug that targets the FGFR4 or related FGFR pathways (confirm with trial site regarding pan-FGFR inhibitors).
• People who have a second active cancer that currently requires treatment.
• People with active cancer that has spread to the brain or spinal cord (though people whose brain metastases are stable and well-controlled after treatment may be considered — confirm with trial site).
• People whose liver tumour takes up 50% or more of the total liver volume.
• People who are unable to swallow tablets or have conditions that significantly affect how the body absorbs oral medication, such as having had the entire stomach removed, reduced stomach function after partial stomach removal, shortened small bowel, or active diarrhoea requiring medication.
• People with severe irritable bowel syndrome requiring ongoing medication.
• People who have had an organ transplant and are taking anti-rejection medications.
• People who have had certain recent cancer treatments before the trial starts, including major surgery, significant radiotherapy, chemotherapy, targeted therapy, immunotherapy, or other anti-cancer treatments — specific waiting periods apply depending on the treatment type (confirm with trial site).
• People who still have significant side effects (above a mild level) from previous cancer treatments, with some exceptions for certain conditions such as hair loss or mild nerve-related symptoms.
• People who have taken strong medications or foods that affect a specific liver enzyme (CYP3A4) within 14 days before the first dose — this includes certain medications as well as grapefruit, pomegranate, starfruit, pomelo, and Seville oranges.
• People with significant heart problems, including severe heart failure, unstable chest pain, a heart attack within the past 6 months, serious heart rhythm problems requiring active treatment, uncontrolled high blood pressure, reduced heart pumping function, or certain abnormal heart rhythm readings on an ECG.
• People with an active infection or unexplained fever above 38.5°C.
• People with active or recent (within 6 months) gastrointestinal bleeding, such as from bleeding veins in the oesophagus or a stomach ulcer.
• People with active hepatitis C infection requiring treatment during the trial, or people who have both hepatitis B and hepatitis C infections at the same time.
• People with a history of immune system deficiency, a positive HIV test, other inherited or acquired immune conditions, or active tuberculosis.
• People with other significant medical, mental health, or social conditions that the trial doctor believes could affect safety or the reliability of trial results.
• People with a specific type of blood clot in the main vein of the liver (type IV portal vein tumour thrombus).

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