Study on AZD5851 for Advanced or Returning Liver Cancer with GPC3 Marker

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06084884

Provider View

This clinical trial is testing a new drug, AZD5851, to see if it is safe and effective for adults with advanced or returning liver cancer that has a specific marker called GPC3. The study is for patients who have not responded to previous treatments or could not tolerate them.

Patient Parameters

Program Overview

This study is exploring a new treatment, AZD5851, for adults with advanced or returning liver cancer that has a specific marker known as GPC3. The trial aims to assess the safety and effectiveness of the drug in patients who have not had success with previous treatments or could not tolerate them. Participants will receive the drug and be monitored for its effects on their cancer and overall health.

Description

This clinical trial is the first to test AZD5851 in humans. It is an open-label study, meaning both the researchers and participants know what treatment is being given. The study will take place at multiple centers and will focus on understanding how safe and tolerable AZD5851 is, as well as its ability to fight cancer. Researchers will also study how the drug moves through the body, its effects on the immune system, and how the body responds to it. The trial is for adults with advanced or returning liver cancer that has a GPC3 marker, who have not responded to or could not tolerate at least one previous treatment. Participants will be closely monitored throughout the study to ensure their safety and to evaluate the drug's impact on their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and agree to participate by signing a consent form.
  • Have advanced or returning liver cancer that cannot be removed by surgery, confirmed by medical tests.
  • Have tried at least one standard treatment for liver cancer that did not work or was not tolerated.
  • Have a tumor with the GPC3 marker, confirmed by a lab test.
  • Be at a specific stage of liver cancer (Barcelona Clinic Liver Cancer Stage B or C) before certain procedures.
  • Have a Child-Pugh score of Grade A, indicating good liver function.
  • If infected with hepatitis B or C, must be receiving treatment for these infections.

Exclusion Criteria

  • Have had recent or past bleeding in the digestive tract or from esophageal varices within the last year.
  • Have had a liver transplant or are on a waiting list for one.
  • Have significant fluid buildup in the abdomen (ascites).
  • Have a blood clot in the main portal vein or tumor invasion in certain veins.
  • Have uncontrolled illnesses or active infections.
  • Test positive for HIV.
  • Have had liver-related brain issues in the past year.
  • Have severe autoimmune diseases requiring treatment in the past year.
  • Have had previous CAR-T therapy or treatments targeting GPC3.
  • Have received any cancer treatment within a short period before starting the study.

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