NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	GPC3+ Advanced/Recurrent Hepatocellular Carcinoma
Date of first enrollment	28/05/2025
Target sample size	16
Countries of recruitment	United States,Japan,Republic of Korea,Japan
Study type	Interventional
Intervention(s)	[Experimental: AZD5851] Subjects will receive AZD5851 following 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide). [Biological: 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. - Other Names: - Cell Therapy

Outcome(s)

Primary Outcome

[Outcome Measure] 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 [Measure Description] 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 [Time Frame] Through study completion, an average of 2 years

Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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 or less 21 days (whichever is shortest).