Summary

Eligibility
for people ages 18-130 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Bridget Keenan
Headshot of Bridget Keenan
Bridget Keenan

Description

Summary

A Phase I/II study to evaluate AZD5851 in patients with GPC3+ advanced/recurrent hepatocellular carcinoma.

Official Title

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

Details

This first-time in human, single-arm, open-label multicentre Phase I/II study will evaluate the safety, tolerability, antitumour activity, cellular kinetics, pharmacodynamics, and immunogenicity of AZD5851 in adult participants with GPC3+ advanced/recurrent HCC, where at least one line of prior therapy has failed/or was intolerable, or participant/investigator decision.

Keywords

Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasm, advanced HCC, HCC, Metastatic Liver Cancer, CAR-T, CART, AZD5851, T-cell, Cell Therapy, Carcinoma

Eligibility

You can join if…

Open to people ages 18-130

  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.

You CAN'T join if...

  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).

Locations

  • Research Site accepting new patients
    San Francisco California 94143 United States
  • Research Site accepting new patients
    Duarte California 91010 United States

Lead Scientist at UCSF

  • Bridget Keenan
    I am a physician scientist who works in translational cancer research and medical oncology. My clinical practice is in the Cancer Immunotherapy Clinic, where I work with patients with solid organ cancers who are being treated on early phase immunotherapy trials. I also attend on the Oncology Consult inpatient service.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT06084884
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 84 study participants
Last Updated