Clinical Trial 23536

• Overview

  Study 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

  Summary:

  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.

  Objective:

  Primary Objectives: *To assess the safety and tolerability of AZD5851 and determine the RDE in participants with GPC3+ advanced/recurrent HCC *To assess the safety and tolerability of AZD5851 in participants with GPC3+ advanced/recurrent HCC Secondary Objectives: *To estimate the antitumour activity of AZD5851 in participants with GPC3+ advanced/recurrent HCC *To investigate the CK of AZD5851 by ddPCR in participants with GPC3+ advanced/recurrent HCC

• Treatments

  Therapies:

  Cell Therapy; Chemotherapy (NOS)

  Medications:

  AZD5851 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

• Inclusion Criteria

  Key Inclusion Criteria:
  • Participant must be 18 years or older and has voluntarily agreed to participate by giving written informed consent.
  • Participants with confirmed advanced/recurrent or metastatic and/or unresectable HCC based on histopathological findings
  • Completed or were unable to tolerate at least one prior line of standard systemic therapy for HCC and/or participant/investigator decision.
  • GPC3-positive tumour as determined by a central laboratory using an analytically validated IHC assay
  • Barcelona Clinic Liver Cancer Stage B (if not amenable to local treatment/surgery) or C prior to apheresis
  • Child-Pugh score: Grade A
  • Participants with HBV and HCV undergoing management of these infections per institutional practice.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Active or prior documented gastrointestinal (GI) variceal bleed or history of upper GI bleeding, ulcers, or esophageal varices with bleeding within 12 months
  • History of liver transplantation or on waiting list
  • Current clinically significant ascites
  • Main portal vein thrombus, or tumor thrombus invasion of mesenteric vein / inferior vena cava
  • Uncontrolled intercurrent illness
  • Active Infections
  • Positive serology for HIV
  • History of hepatic encephalopathy within 12 months prior to treatment allocation
  • History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.
  • Prior treatment with any CAR-T therapy directed at any target or any therapy that is targeted to GPC3.
  • 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).

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