A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma
ATHENA
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
1 other identifier
interventional
94
3 countries
18
Brief Summary
A Phase I/II study to evaluate AZD5851 in patients with GPC3+ advanced/recurrent hepatocellular carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hepatocellular-carcinoma
Started Dec 2023
Typical duration for phase_1 hepatocellular-carcinoma
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2023
CompletedFirst Posted
Study publicly available on registry
October 16, 2023
CompletedStudy Start
First participant enrolled
December 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 13, 2027
March 9, 2026
March 1, 2026
4 years
October 3, 2023
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
Through study completion, an average of 2 years
Secondary Outcomes (12)
1. Proportion of participants with a confirmed Complete Response (CR) or Partial Response (PR)
Through study completion, an average of 2 years
2. Interval between the date of AZD5851 infusion dose and first documented evidence of CR or PR
Through study completion, an average of 2 years
3. Proportion of participants who have a confirmed CR, PR, or who have stable disease (SD) for at least 5 weeks after the date of AZD5851 infusion
Through study completion, an average of 2 years
4. The proportion of participants who have a confirmed response (CR/PR) with a duration of at least a specific number of months
Through study completion, an average of 2 years
5. The best response the participant achieved according to RECIST v1.1
Through study completion, an average of 2 years
- +7 more secondary outcomes
Study Arms (1)
AZD5851
EXPERIMENTALSubjects will receive AZD5851 following 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide).
Interventions
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.
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (18)
Research Site
Phoenix, Arizona, 85054, United States
Research Site
Duarte, California, 91010, United States
Research Site
Orange, California, 92868, United States
Research Site
San Francisco, California, 94143, United States
Research Site
Washington D.C., District of Columbia, 20007, United States
Research Site
Jacksonville, Florida, 32224, United States
Research Site
Atlanta, Georgia, 30322, United States
Research Site
Westwood, Kansas, 66205, United States
Research Site
Rochester, Minnesota, 55905, United States
Research Site
Hackensack, New Jersey, 07601, United States
Research Site
New York, New York, 10065, United States
Research Site
Columbus, Ohio, 43210, United States
Research Site
Portland, Oregon, 97239, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
Pittsburgh, Pennsylvania, 15237, United States
Research Site
Kashiwa, 227-8577, Japan
Research Site
Osakasayama-shi, 589-8511, Japan
Research Site
Seoul, 03080, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open-label
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2023
First Posted
October 16, 2023
Study Start
December 14, 2023
Primary Completion (Estimated)
December 13, 2027
Study Completion (Estimated)
December 13, 2027
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.