← Back to Search

Monoclonal Antibodies

AZD5851 for Liver Cancer (ATHENA Trial)

Phase 1 & 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Barcelona Clinic Liver Cancer Stage B (if not amenable to local treatment/surgery) or C prior to apheresis

Participants with confirmed advanced/recurrent or metastatic and/or unresectable HCC based on histopathological findings

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

ATHENA Trial Summary

This trial tests a new drug to treat advanced liver cancer.

Who is the study for?

This trial is for adults with advanced or recurrent liver cancer (Hepatocellular Carcinoma) that can't be removed by surgery. Participants must have tried at least one standard treatment, have a specific protein on their tumor (GPC3+), and manage any hepatitis infections. They can't join if they've had HIV, liver transplant, certain blood vessel issues in the liver, severe illnesses or infections, recent hepatic encephalopathy, autoimmune diseases needing strong medication, previous CAR-T therapy targeting GPC3 or other treatments too close to the start of this trial.Check my eligibility

What is being tested?

The study tests AZD5851 in patients with a particular type of liver cancer marked by GPC3+ proteins. It's an early-stage trial to see how safe it is and how well it works. The first phase checks for safety and dosage; the second phase assesses effectiveness against the disease.See study design

What are the potential side effects?

While not specified here, typical side effects from similar cancer drugs may include nausea, fatigue, immune system reactions like fever or chills during infusion (infusion reactions), potential organ inflammation due to immune response activation and increased risk of infection.

ATHENA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My liver cancer is at an advanced stage and cannot be treated with surgery.

Select...

My liver cancer cannot be removed by surgery and has spread.

Select...

My tumor is GPC3 positive according to a specific lab test.

Select...

My liver function is good.

ATHENA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

1. Proportion of participants with a confirmed Complete Response (CR) or Partial Response (PR)

10. Pharmacokinetics -time to peak serum concentration of AZD5851

11. Pharmacokinetics -time to last measurable serum concentration of AZD5851

+9 more

ATHENA Trial Design

1Treatment groups

Experimental Treatment

Group I: AZD5851Experimental Treatment1 Intervention

Subjects will receive AZD5851 following 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide).

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,612,516 Total Patients Enrolled

2 Trials studying Liver Cancer

1,040 Patients Enrolled for Liver Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age cap for participants in this research project?

"This study is looking for participants who are at least 18 years of age and not beyond their 130th birthday."

Answered by AI

Are there any open slots for participation in this experiment?

"The clinical trial mentioned is not currently recruiting, as noted on the clinicaltrials.gov website. Initially posted in December of 2023 and last updated by October 12th of that same year, this study has yet to be reopened for enrollment; however, 2702 other trials are actively looking for volunteers right now."

Answered by AI

Are there multiple sites in which this research project is being conducted within the city limits?

"At this time, 10 medical centres are enrolling patients for the trial. These sites can be found in San Francisco, Westwood and Rochester as well as other cities across America. To reduce any travel strain associated with participation, it is recommended to select the closest facility you deem suitable."

Answered by AI

Is there an opportunity for me to enroll in this trial?

"To participate in this medical trial, the requisite qualifications are to have been diagnosed with liver cancer and age between 18-130. The research team is looking for approximately 84 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06084884.

All > Kansas City > Hepatocellular Carcinoma