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

Eligibility Criteria

• 1. Participant must be 18 years or older and has voluntarily agreed to participate by giving written informed consent.
• 2. Participants with confirmed advanced/recurrent or metastatic and/or unresectable HCC based on histopathological findings
• 3. Completed or were unable to tolerate at least one prior line of standard systemic therapy for HCC and/or participant/investigator decision.
• 4. GPC3-positive tumour as determined by a central laboratory using an analytically validated IHC assay
• 5. Barcelona Clinic Liver Cancer Stage B (if not amenable to local treatment/surgery) or C prior to apheresis
• 6. Child-Pugh score: Grade A
• 7. Participants with HBV and HCV undergoing management of these infections per institutional practice.
• 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).