ACTIVE_NOT_RECRUITING

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

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Conditions

Hepatocellular CarcinomaLiver CancerLiver Neoplasmadvanced HCCHCCMetastatic Liver CancerCAR-TCARTAZD5851T-cellCell Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-12-14
Study Completion:2027-12-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06084884

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 130 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participant must be 18 years or older and has voluntarily agreed to participate by giving written informed consent.
  2. 2. Participants with confirmed advanced/recurrent or metastatic and/or unresectable HCC based on histopathological findings
  3. 3. Completed or were unable to tolerate at least one prior line of standard systemic therapy for HCC and/or participant/investigator decision.
  4. 4. GPC3-positive tumour as determined by a central laboratory using an analytically validated IHC assay
  5. 5. Barcelona Clinic Liver Cancer Stage B (if not amenable to local treatment/surgery) or C prior to apheresis
  6. 6. Child-Pugh score: Grade A
  7. 7. Participants with HBV and HCV undergoing management of these infections per institutional practice.
  1. 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. 2. History of liver transplantation or on waiting list
  3. 3. Current clinically significant ascites
  4. 4. Main portal vein thrombus, or tumor thrombus invasion of mesenteric vein / inferior vena cava
  5. 5. Uncontrolled intercurrent illness
  6. 6. Active Infections
  7. 7. Positive serology for HIV
  8. 8. History of hepatic encephalopathy within 12 months prior to treatment allocation
  9. 9. History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.
  10. 10. Prior treatment with any CAR-T therapy directed at any target or any therapy that is targeted to GPC3.
  11. 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).

Contacts and Locations

Study Locations (Sites)

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, 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

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-14
Study Completion Date2027-12-13

Study Record Updates

Study Start Date2023-12-14
Study Completion Date2027-12-13

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Hepatocellular Carcinoma