Status:
ACTIVE_NOT_RECRUITING
A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma
Lead Sponsor:
AstraZeneca
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-130 years
Phase:
PHASE1
PHASE2
Brief Summary
A Phase I/II study to evaluate AZD5851 in patients with GPC3+ advanced/recurrent hepatocellular carcinoma.
Detailed Description
This first-time in human, single-arm, open-label multicentre Phase I/II study will evaluate the safety, tolerability, antitumour activity, cellular kinetics, pharmacodynamics, and immunogenicity of AZ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
December 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 13 2027
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT06084884
Start Date
December 14 2023
End Date
December 13 2027
Last Update
December 2 2025
Active Locations (18)
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1
Research Site
Phoenix, Arizona, United States, 85054
2
Research Site
Duarte, California, United States, 91010
3
Research Site
Orange, California, United States, 92868
4
Research Site
San Francisco, California, United States, 94143