AZD5851 for Liver Cancer

(ATHENA Trial)

Recruiting at 19 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

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

Disqualifiers: HIV, Liver transplant, GI bleed, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

94 Participants Needed

Trial Summary

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.

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.

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.

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.

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

Treatment Details

Interventions

• AZD5851

Trial Overview 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.

Participant Groups

Group I: AZD5851 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology