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Active, not recruiting Phase 1/2

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

NCT06084884 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 1/2
Started
2023-12-14
Last updated
2026-08-19

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

AZD5851 →

AZD5851: Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce AZD5851. During AZD5851 production, subjects may receive bridging therapy for disease control. Upon successful generation of AZD5851 product, subjects will receive treatment with AZD5851 therapy. Study treatment will include lymphodepleting chemotherapy followed by one dose of AZD5851 administered by intravenous (IV) infusion.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion 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. 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).

Primary outcome measure(s)

  • 1. Incidence of participants with dose-limiting toxicities (DLTs), adverse events (AEs), including adverse events of special interest (AESI) and serious adverse events (SAEs). Determination of the recommended dose of AZD5851 for expansion phase — Through study completion, an average of 2 years
    Determine if treatment with AZD5851 is safe and tolerable through assessment of DLTs, AEs, SAEs and changes from baseline in vital signs, ECGs, and laboratory parameters

Trial sites (19)

FacilityCityRegionStatus
Research Site Phoenix Arizona
Research Site Duarte California
Research Site Los Angeles California
Research Site Orange California
Research Site San Francisco California
Research Site Washington D.C. District of Columbia
Research Site Jacksonville Florida
Research Site Atlanta Georgia
Research Site Westwood Kansas
Research Site Rochester Minnesota
Research Site Hackensack New Jersey
Research Site New York New York
Research Site Columbus Ohio
Research Site Portland Oregon
Research Site Philadelphia Pennsylvania
Research Site Pittsburgh Pennsylvania
Research Site Kashiwa Japan
Research Site Osakasayama-shi Japan
Research Site Seoul South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06084884 on ClinicalTrials.gov ↗ ← All trials in South Korea