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 aged 18 or older.
• People who have been diagnosed with an advanced solid tumour, confirmed through a tissue or cell sample.
• People whose cancer has not responded to at least one standard treatment, for whom no standard treatment is available, or who were unable to tolerate standard treatment.
• People who have at least one tumour that can be measured on a scan, according to standard measurement guidelines.
• People who are generally able to carry out daily activities with little or no limitation (based on a standard medical rating scale called ECOG, scored 0 or 1).
• People with an expected survival of at least 3 months.
• People whose blood counts and organ function (including kidneys, liver, and blood clotting) meet specific laboratory thresholds set by the trial, without having received a blood transfusion or certain blood-boosting treatments in the 14 days before testing (confirm with trial site for exact values).
• People who are able to have children (both male and female) and agree to use reliable contraception during the trial and for at least 180 days after the last dose; women who could become pregnant must have a negative blood pregnancy test within 7 days before joining.
• People who understand the trial and sign a consent form voluntarily.

Who may not be able to join:

• People who have previously received a treatment targeting a protein called GPC3.
• People with spinal cord compression, active or untreated brain metastases, or cancer spread to the membranes around the brain; people with previously treated and clinically stable brain metastases for at least 4 weeks, with no signs of worsening on imaging, may still be considered (confirm with trial site).
• People who take long-term immune-suppressing medications (such as cyclosporine) or daily steroid tablets above a certain dose, not including nasal sprays, inhalers, or other topical steroid treatments.
• People who still have significant side effects from previous cancer treatments that have not sufficiently resolved, with some exceptions for effects considered low-risk by the doctor (such as hair loss).
• People who have received any cancer treatment or participated in another experimental treatment within 4 weeks or 5 half-lives of the study drug (whichever is shorter) before starting, or certain traditional Chinese medicines with anti-tumour indications within 14 days before starting.
• People who experienced severe immune-related side effects (grade 3 or higher) from previous immunotherapy.
• People currently taking part in another interventional clinical trial (participation in observational studies or follow-up phases of other trials is generally allowed).
• People who had major surgery within 28 days before starting the trial, or who have a planned tumour removal surgery during the study.
• People who have had significant bleeding in the 4 weeks before starting, have conditions considered high-risk for bleeding by the treating doctor, or have an inherited bleeding disorder.
• People with a known severe allergy to the study drug or any of its ingredients.
• People who have an active bacterial, fungal, or viral infection requiring intravenous treatment within 14 days before joining (preventive treatment without active infection symptoms is generally allowed; people with viral hepatitis receiving antiviral treatment may still be considered).
• People with uncontrolled fluid build-up around the lungs, abdomen, or heart that has required frequent draining or other procedures within 14 days before starting.
• People who have had an organ transplant or bone marrow/stem cell transplant from a donor.
• People with immune deficiency conditions, including those who are HIV-positive.
• People with certain levels of active hepatitis B or hepatitis C infection in the blood (confirm with trial site for specific thresholds).
• People who received treatment for tuberculosis within the 2 years before starting the trial.
• People with interstitial lung disease or severely reduced lung function.
• People with a history of inflammatory bowel disease or chronic diarrhoea.
• People with serious heart or blood vessel conditions, including certain abnormal heart rhythms, a heart attack, heart failure, stroke, or other significant cardiovascular events within the past 6 months; reduced heart pumping function; a heart condition affecting the heart's electrical timing; or blood pressure that remains too high despite treatment.
• People who have had another active cancer within the past 2 years, with the exception of certain localised cancers that have been fully treated and cured.
• People who have received a live vaccine within 28 days before starting (inactivated vaccines such as standard flu shots are generally permitted).
• People who are pregnant or breastfeeding.
• People whom the treating doctor considers unsuitable for the trial for other reasons, such as certain mental health conditions, psychiatric disorders that could affect ability to follow the trial requirements, or specific tumour-related complications such as a blood clot in the main vein supplying the liver.

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