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 able to understand and are willing to sign a written consent form to take part in the study.
• People who have been diagnosed with fibrolamellar hepatocellular carcinoma (a rare type of liver cancer) or another type of cancer that has spread or cannot be surgically removed, confirmed by laboratory testing of tissue.
• People with a cancer other than fibrolamellar hepatocellular carcinoma may be eligible if their cancer has continued to grow after treatment and no further standard treatments are available, if they are considered unsuitable for further standard treatments, if they are unwilling to receive further standard treatments, or if no standard treatment exists for their cancer.
• People whose cancer has a specific genetic change called the DNAJB1-PRKACA fusion, confirmed by specialised genetic testing.
• People aged 18 years or older.
• People who are generally well enough to carry out normal daily activities with little or no limitation (assessed using a standard medical scale called ECOG, score of 0 or 1).
• People whose cancer can be measured on scans according to specific criteria used in the trial.
• People with a negative COVID-19 rapid antigen test (while the World Health Organization continues to declare a pandemic).
• People whose blood tests show that their immune cells, platelets, kidneys, and liver are functioning at an adequate level (confirm with trial site for specific values).
• People who test negative for Hepatitis B (or have no signs of active infection), negative for Hepatitis C, and negative for HIV, tested within 6 weeks before joining the study.
• People who are willing to use two effective forms of contraception from the time of signing consent until 5 months after the last dose of a study drug (applies to women who could become pregnant and men whose partners could become pregnant, if sexually active).
• Women who could become pregnant must have two negative pregnancy tests before receiving the first study treatment.
• Women who are past menopause or who cannot become pregnant for confirmed medical reasons.

Who may not be able to join:

• People who are pregnant or breastfeeding.
• People who are unable or unwilling to follow the study schedule and requirements.
• People who have received chemotherapy, other systemic cancer treatment, or radiotherapy within 14 days before the first study treatment.
• People who are currently taking part in, or have taken part in, another clinical trial involving an experimental treatment within the past 30 days.
• People who have had major surgery within 28 days before the first study treatment.
• People who have not yet recovered sufficiently from side effects of previous cancer treatments (with some exceptions such as hair loss).
• People who have previously experienced a serious immune-related reaction (grade 3 or above) caused by immunotherapy drugs.
• People who have received immunotherapy drugs within 28 days before the first study treatment.
• People who have received a live vaccine within 28 days before the start of study treatment.
• People who have a known allergy or sensitivity to any of the study drugs, or to products derived from Chinese hamster ovary cells used in manufacturing certain medicines.
• People who have a history of severe allergic reactions to certain types of laboratory-made antibody treatments.
• People who have an active autoimmune disease that has required treatment that suppresses the immune system at any point in the past 2 years.
• People who have received an organ or tissue transplant from another person (including corneal transplants), or who have previously had a bone marrow or stem cell transplant from a donor.
• People who have a diagnosed condition that causes a weakened immune system.
• People who are taking immune-suppressing medications or steroid medications above a certain dose within 7 days before the study treatment.
• People who have symptomatic lung disease affecting the lung tissue (interstitial lung disease).
• People who have cancer that has spread to the brain or the lining of the brain, if it has not been treated or is still causing symptoms.
• People who have other serious uncontrolled health conditions, including uncontrolled infections, serious heart conditions, uncontrolled mental health conditions, or a separate active cancer unrelated to the one being studied.

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