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A study to evaluate the safety and effectiveness of AZD9793 in adults with advanced or metastatic liver cancer

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to evaluate the safety and effectiveness of a new drug called AZD9793. The investigation focuses on adults who have Hepatocellular Carcinoma, which is a type of primary liver cancer, or other types of Advanced or Metastatic Solid Tumours. These are cancers that have grown significantly or have spread to other parts of the body. The treatment, AZD9793, is a type of T cell-engaging Antibody designed to help the body's immune system recognize and attack cancer cells that express a specific protein known as Glypican-3.

Participants in the study will receive the medication through an injection or infusion, which can be given into a vein, under the skin, or into a muscle. The study is designed to find the most appropriate dose and to see how the medicine moves through the body. During the course of the study, the way the drug affects the body and its ability to shrink tumors will be monitored. This process involves gradually increasing the amount of medicine given to certain groups to ensure it is safe for use.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of study medication
The study drug, azd9793, is administered via injection or infusion. this means the medicine is delivered into the body through the vein, under the skin, or into a muscle.
This medication is a t cell-engaging antibody, which is a type of medicine designed to help the body's immune system (the natural defense system) target specific cells.
Step 2
Monitoring and evaluation
Safety and tolerability, which refers to how well the body handles the medicine, are monitored throughout the process.
The way the drug moves through the body and how it affects biological functions is tracked.
The size of the tumors and how they respond to the treatment are measured to evaluate the effectiveness of the medication.

Who can join the trial?

12 criteria

You must be 18 years of age or older at the time you agree to join the study.
You must have a Child-Pugh Score class A, which is a system used to measure how well your liver is still functioning.
For the first part of the study, you must have already received at least one type of standard systemic therapy (treatment that travels through the whole body, like chemotherapy) for your liver cancer.
For the second part of the study, you must not have had more than one previous treatment for your advanced or spreading cancer.
Your tumor must be GPC3 positive, which means a specific protein called GPC3 is found on the surface of your cancer cells, as confirmed by a special lab test.
You must have at least one measurable lesion, which is a tumor or area of cancer that is large enough to be clearly seen and measured on medical scans.
Your ECOG Performance Status must be 0 or 1, which is a scale used to measure how well you can perform daily activities and your overall physical strength.
It is expected that you will live for at least 12 weeks.
Your organ and bone marrow function must be healthy and meet specific requirements based on blood tests taken within 28 days before your first dose.
You must use contraception (methods to prevent pregnancy) according to the rules set by the study.
Your liver cancer must be confirmed as advanced, recurrent (coming back), metastatic (spreading to other parts of the body), or unresectable (cannot be removed by surgery) through a tissue sample examination.
Your cancer must be at Barcelona Clinic Liver Cancer (BCLC) stage B or C, which are specific stages used to describe how much the liver cancer has progressed and how it affects your health.

Who cannot join the trial?

15 criteria

You have ongoing harmful side effects from previous cancer treatments, such as immune-related adverse events, which are health problems caused by the body's immune system attacking healthy cells. This applies to any side effect rated as Grade 2 or higher, which means a moderate to severe issue, except for skin color changes (vitiligo), nerve damage (peripheral neuropathy), hair loss (alopecia), or hormone issues that are managed with medicine.
You have a history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS), which are rare and serious conditions where the immune system becomes overactive and causes excessive inflammation.
You have had an autoimmune disorder (a condition where the immune system attacks the body) or an inflammatory disorder (a condition involving swelling and irritation) that is active or was documented within the last 3 years.
You have certain cardiac conditions, which are problems related to the heart.
You have had a thromboembolic event, such as a blood clot, within the last 3 months.
You have central nervous system (CNS) pathology, which means diseases or damage affecting the brain or spinal cord, or CNS metastases, which are cancer cells that have spread to the brain or spinal cord, that are active or unstable.
You have an active infectious disease, such as HIV, or an infection caused by fungi or bacteria that is not under control.
You have taken another experimental medicine in a clinical study within the last 21 days or within a specific timeframe based on how long the drug stays in your body (known as half-lives).
You have received CAR-T cell therapy, a type of immune system treatment, within the last 6 months.
You have a known allergy or sensitivity to the study drug or any of its excipients, which are the inactive ingredients used to make the medicine.
You need long-term immunosuppressive therapy, which is medicine used to lower or suppress the activity of your immune system, including high doses of steroids.
You have previously received any treatment that specifically targets GPC3, which is a protein found on certain cancer cells.
You have had radiation therapy within the last 14 days, unless it was used to prevent tumor lysis syndrome (TLS) (a complication caused by a rapid breakdown of cancer cells) or other specific side effects.
You have had major surgery within the last 14 days and have not had enough time to heal properly.
You experienced severe side effects called cytokine release syndrome (CRS), a condition where the body releases too many signals that cause intense inflammation, or immune effector cell-associated neurotoxicity (ICANS), which is brain dysfunction caused by certain immune treatments, after previous immunotherapy.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitario De Navarra
Verified
Pamplona, Spain
Hospital Vall d’Hebron
Verified
Barcelona, Spain

Trial locations

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Investigated drugs

AZD9793 is an experimental drug being tested to see if it can help the body's immune system fight cancer. It works by attaching to a specific protein found on certain types of tumor cells, which helps direct the body's own immune cells, known as T cells, to find and attack those cancer cells.

What is already known about the treatment

AZD9793 - This medication is an experimental injection given directly into a vein, under the skin, or into a muscle. It is currently being studied in clinical trials to see if it can effectively treat advanced or spreading solid tumors, such as liver cancer. As a type of immunotherapy, it works by attaching to a specific protein called Glypican-3 on the surface of cancer cells to help the body's own immune system find and destroy them.

Investigated diseases

Hepatocellular Carcinoma - This is a type of cancer that develops in the main cells of the liver. It often starts in the liver cells and can grow into a large mass. The disease can begin in a single area of the liver or spread to multiple locations. As it progresses, the abnormal cells may move from the liver to other parts of the body. This condition is often associated with existing liver damage or scarring.