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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

A Phase I/II study to evaluate AZD5851 in patients with GPC3+ advanced/recurrent hepatocellular carcinoma.

Key facts

Study ID

NCT06084884

Run by

AstraZeneca

People needed

94

Starts

2023-12-14

Expected to finish

2027-12-13

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Active or prior documented gastrointestinal (GI) variceal bleed or history of upper GI bleeding, ulcers, or esophageal varices with bleeding within 12 months
• History of liver transplantation or on waiting list
• Current clinically significant ascites
• Main portal vein thrombus, or tumor thrombus invasion of mesenteric vein / inferior vena cava
• Uncontrolled intercurrent illness
• Active Infections
• Positive serology for HIV
• History of hepatic encephalopathy within 12 months prior to treatment allocation
• History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.
• Prior treatment with any CAR-T therapy directed at any target or any therapy that is targeted to GPC3.
• 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).

Where it is running

• Research Site — Duarte, California, United States
• Research Site — Orange, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Westwood, Kansas, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — Hackensack, New Jersey, United States
• Research Site — New York, New York, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Portland, Oregon, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Kashiwa, Japan
• Research Site — Osakasayama-shi, Japan
• Research Site — Seoul, South Korea

Full record on ClinicalTrials.gov

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