AZD5851 for Liver Cancer
(ATHENA Trial)

Recruiting in Palo Alto (17 mi)

+19 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: AstraZeneca

Must not be taking: Steroids, Immunosuppressants, CAR-T

Disqualifiers: HIV, Liver transplant, GI bleed, others

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing AZD5851, a new drug, in adults with advanced liver cancer that has a specific marker (GPC3) and hasn't responded to other treatments. The drug aims to target and kill these specific cancer cells.

Will I have to stop taking my current medications?

The trial requires that you stop taking any anticancer therapy at least 21 days before starting the study treatment, or within 5 half-lives of the medication, whichever is shorter. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Eligibility Criteria

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.

Inclusion Criteria

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

I am over 18 and have agreed to join the study.

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

+4 more

Exclusion Criteria

I do not have any unmanaged ongoing illnesses.

I have a severe autoimmune disease treated with steroids or other immune-suppressants in the last year.

I have not had CAR-T therapy or treatments targeting GPC3.

+8 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

Participants receive 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide) before AZD5851 infusion

1 week

Treatment

Participants receive AZD5851, a CAR-T therapy directed against GPC3

2 years

Follow-up

Participants are monitored for safety, efficacy, and pharmacokinetics of AZD5851

2 years

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: AZD5851Experimental Treatment1 Intervention

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