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Evaluating AZD5851 for advanced liver cancer

A Phase I/II Open-Label Study to Evaluate the Safety, Cellular Kinetics and Efficacy of AZD5851, a Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Directed Against GPC3 in Adult Participants With Advanced/Recurrent Hepatocellular Carcinoma: ATHENA

Phase1; Phase2 Interventional AstraZeneca · NCT06084884

This study is testing a new treatment called AZD5851 to see if it can help adults with advanced liver cancer who haven't had success with other therapies.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment94 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsCAR-T, chemotherapy, immunotherapy
Locations20 sites (Phoenix, Arizona and 19 other locations)
Trial IDNCT06084884 on ClinicalTrials.gov

What this trial studies

This Phase I/II study aims to assess the safety and effectiveness of AZD5851 in treating adults with GPC3-positive advanced or recurrent hepatocellular carcinoma (HCC) who have not responded to or could not tolerate previous therapies. The study will be conducted as a single-arm, open-label trial across multiple centers, focusing on various factors such as antitumor activity, pharmacodynamics, and immunogenicity. Participants must have confirmed advanced HCC and meet specific eligibility criteria, including a positive GPC3 tumor status.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with GPC3-positive advanced or recurrent hepatocellular carcinoma who have failed or could not tolerate at least one prior line of therapy.

Not a fit: Patients with active gastrointestinal bleeding, a history of liver transplantation, or those who are not GPC3-positive may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced liver cancer who have limited treatment choices.

How similar studies have performed: While this approach is novel in targeting GPC3-positive tumors, similar studies have shown promise in treating advanced liver cancer with targeted therapies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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).

Where this trial is running

Phoenix, Arizona and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hepatocellular CarcinomaLiver CancerLiver Neoplasmadvanced HCCHCCMetastatic Liver CancerCAR-TCART
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.