Phase 2 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 18 or older at the time of signing the consent form.
• People whose tumour tests positive for a protein called GPC3, confirmed by a central laboratory. People who have previously had treatment targeting GPC3 must have new tumour tissue tested after that prior treatment ended.
• People who have at least one tumour that can be measured using standard imaging criteria (called RECIST v1.1).
• People with a good general health and activity level, rated 0 or 1 on a standard scale used by doctors (called ECOG Performance Status).
• People with a life expectancy of at least 12 weeks.
• People whose kidneys, liver, bone marrow, and other organs are functioning well enough, as measured by blood tests taken within 28 days before the first dose.
• People using contraception that meets the requirements set out in the study protocol.
• People with confirmed advanced, returned, spread, or inoperable liver cancer (HCC), proven by a tissue biopsy according to World Health Organization standards.
• People whose liver cancer is classified as Barcelona Clinic Liver Cancer (BCLC) stage B (where local treatments are not suitable) or stage C.
• People with liver function rated as Child-Pugh class A (a measure of how well the liver is working).
• Part A of the trial: People who have already received at least one standard treatment for HCC, and where joining a clinical study is considered the best next option.
• Part B of the trial: People who have received no more than one prior treatment for advanced, spread, or inoperable HCC.

Who may not be able to join:

• People who still have significant side effects (grade 2 or higher) from previous cancer treatment, with some exceptions such as skin pigment changes, certain nerve problems, hair loss, hormone disorders managed with replacement therapy, or abnormal lab results causing no symptoms.
• People who have taken part in another clinical trial involving an experimental treatment within the last 21 days, or within 5 half-lives of that treatment (whichever is shorter).
• People who have received CAR-T cell therapy within the past 6 months.
• People with a known allergy or sensitivity to the study drug (AZD9793) or any of its ingredients.
• People who need ongoing immune-suppressing medicines, including steroid doses greater than 10 mg of prednisone per day (or an equivalent dose of another steroid).
• People who have received radiation therapy within 14 days before the first dose (some exceptions may apply — confirm with trial site).
• People who have had major surgery within 14 days before the first dose.
• People who have previously had a severe reaction to T-cell engaging therapies or CAR-T cell therapy, specifically a serious cytokine release syndrome or a condition affecting the nervous system called ICANS.
• People with a history of a serious immune condition called hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS).
• People with an active or previously documented autoimmune or inflammatory condition that occurred within the past 3 years.
• People with certain heart conditions as defined by the study protocol (confirm with trial site).
• People who have had a blood clot event within the past 3 months before the scheduled first dose.
• People with cancer that has spread to the brain or spinal cord, or certain other brain-related conditions, within 3 months before signing consent (confirm with trial site).
• People with active HIV, or an uncontrolled active fungal, bacterial, or other serious infection.
• People with specific rare types of liver cancer, including fibrolamellar HCC, sarcomatoid HCC, or a combined liver and bile duct cancer.

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