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 between 18 and 75 years old.
• People who have been diagnosed with liver cancer (hepatocellular carcinoma) that has been confirmed by a tissue sample, and whose cancer is at an advanced stage or cannot be treated with curative intent.
• People who have hepatitis B that is currently inactive, with no detectable hepatitis B virus in the blood.
• People who are able to understand the study information and are willing to sign a consent form agreeing to take part.
• People who have already tried standard treatments that did not work.
• People whose general physical functioning falls within an acceptable range on a standard medical scale (ECOG score of 0–2, meaning someone who is fully active up to someone who is unable to do physical work but can care for themselves) (confirm with trial site).
• People who have at least one measurable area of cancer that can be tracked using standard imaging measurements.
• People whose cancer tissue samples test positive for two specific markers called CREPT and ASGPR, either from existing tissue slides or a new biopsy, meeting specific measurement thresholds (confirm with trial site).
• People whose blood counts and organ function (including blood cells, kidneys, and clotting ability) meet the required levels as confirmed by blood tests.
• People who are expected to live for at least 3 more months.
• People of childbearing potential who agree to use effective contraception during the study and for at least 6 months after the last dose, and women of childbearing potential who have a negative pregnancy blood test within 7 days before enrolling.
• People who are willing and able to attend follow-up visits and stick to the study schedule.

Who may not be able to join:

• People who have received chemotherapy, radiotherapy, immunotherapy, or other cancer treatments within 4 weeks before the first dose (or within 6 weeks for certain specific drugs), or who have taken part in another treatment study within that time. Some exceptions apply for certain oral or targeted therapies taken more than 2 weeks beforehand (confirm with trial site).
• People who are scheduled to have major surgery within 28 days before starting the study treatment (routine diagnostic biopsies are generally permitted).
• People who have received immune-stimulating medications within 4 weeks or 5 half-lives before enrolling (whichever is longer).
• People who have used high-dose steroid tablets or other immune-suppressing medications within 14 days before starting treatment. Some exceptions apply for topical, inhaled, or short-term preventative steroid use.
• People who have an active autoimmune disease, or who have had one within the past 2 years. Some conditions such as vitiligo, certain thyroid conditions, or psoriasis not requiring systemic treatment may be exceptions (confirm with trial site).
• People who have serious liver complications such as fluid build-up in the abdomen that cannot be controlled, significant confusion caused by liver failure, bacterial infection in the abdomen, kidney problems related to liver failure, recent bleeding from veins in the throat or stomach (within 3 months), fluid around the lungs due to liver disease, or complete blockage of a major liver blood vessel.
• People whose blood test results show liver or kidney function outside acceptable ranges, including very high bilirubin, low albumin, poor blood clotting, elevated liver enzymes, low sodium, or high creatinine levels.
• People who are HIV positive or have a known history of AIDS.
• People who test positive for hepatitis C virus.
• People who have significant lung disease, including scarring of the lung tissue, blocked airways, breathing difficulties, or blood oxygen levels below 93%.
• People who still have side effects from previous cancer treatments that have not improved to a mild level or resolved. Some long-lasting but stable side effects may be exceptions (confirm with trial site).
• People with uncontrolled diabetes (very high fasting blood sugar) or serious heart conditions such as a heart attack in the last 6 months, unstable chest pain, or severe heart failure.
• People who have active cancer that has spread to the brain or the lining of the brain and is causing symptoms, or where brain metastases have not responded to local treatment. People with stable, symptom-free brain metastases for at least 28 days without steroid use may be considered (confirm with trial site).
• People who have had another active cancer diagnosed within the past 5 years, with some exceptions for certain low-risk skin cancers, cervical changes, early thyroid cancer, or cancers from which the person has been free for more than 5 years.
• People who have received a live vaccine within 28 days before the first dose, or who would need a live vaccine during the study.
• People who have previously received immunotherapy and experienced unresolved side effects above a mild level, or serious immune-related side effects of grade 3 or above. Also, people who are known to be allergic to any ingredient in the study drug (CREPT-618).
• People who have undergone liver transplant assessment or are planning a liver transplant within 4 weeks before starting the study or during the study.
• People with a diagnosed mental health condition or who are unlikely to follow the study requirements.
• People with a known history of alcohol or drug misuse.
• People who are currently pregnant or breastfeeding, or who have a positive pregnancy blood test within 7 days before starting the study drug.
• People whose overall health condition or blood test results lead the trial doctor to consider participation unsuitable.

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