A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma

Exclusion Criteria

• •1. Active or prior documented gastrointestinal (GI) variceal bleed or history of upper GI bleeding, ulcers, or esophageal varices with bleeding within 12 months
• •2. History of liver transplantation or on waiting list
• •3. Current clinically significant ascites
• •4. Main portal vein thrombus, or tumor thrombus invasion of mesenteric vein / inferior vena cava
• •5. Uncontrolled intercurrent illness
• •6. Active Infections
• •7. Positive serology for HIV
• •8. History of hepatic encephalopathy within 12 months prior to treatment allocation
• •9. History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.
• •10. Prior treatment with any CAR-T therapy directed at any target or any therapy that is targeted to GPC3.
• •11. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolisation, or monoclonal antibodies, investigational product) within 5 half-lives or ≤ 21 days (whichever is shortest).