Recruiting

A study to investigate the safety and effects of ceralasertib, tremelimumab, and durvalumab in adults with various solid tumors

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study focuses on individuals with various types of cancer, including Non-small cell lung cancer, Small cell lung cancer, and Hepatocellular carcinoma, which is a type of liver cancer. The research aims to investigate the safety and how the body processes a specific medication when it is given in a different way. The study involves the use of durvalumab, an immunotherapy drug, and a combination known as AZD4773, which contains durvalumab and hyaluronidase. Unlike the standard method of giving this medicine through an IV infusion, which is a liquid delivered directly into a vein, this study explores giving the drug via subcutaneous injection, meaning it is injected into the fatty tissue just under the skin.

The purpose of the study is to characterize the pharmacokinetics, which describes how a drug moves through the body, specifically for the subcutaneous version of the medicine. Participants will be monitored to ensure the safety of this administration method and to see how much of the medicine stays in the bloodstream over time. During the course of the study, different doses may be used to determine the most appropriate amount for patients.

The research process

The trial runs in 1 step.

Step 1
Study participation and medication administration
The study involves receiving durvalumab, which is an injectable medicine, through a subcutaneous injection. a subcutaneous injection is a method where the medicine is delivered into the fatty tissue located just under the skin.
The main goal is to observe how the body processes this specific way of delivering the medicine and to ensure it is safe.

Who can join the trial?

8 criteria

You must be 18 years of age or older at the time you agree to join the study.
You must have an ECOG performance status of 0 or 1, which means you are able to carry out most daily activities and are generally able to walk and work with little or no restriction.
Your organ and marrow function must be adequate, meaning your organs (like the liver or kidneys) and your bone marrow (the part of your body that makes blood cells) must be working well according to the study rules.
Your cancer must be confirmed by histology or cytology, which means a doctor has looked at your cells under a microscope to prove the presence of cancer.
You may have locally advanced unresectable Stage III non-small cell lung cancer, which is a type of lung cancer that is advanced but cannot be removed by surgery, and you must have completed radiation and chemotherapy without the cancer getting worse.
You may have unresectable hepatocellular carcinoma, which is a type of liver cancer that cannot be removed by surgery, and you must meet specific health scores for liver function and have not received previous whole-body treatments.
You may have limited-stage small cell lung cancer, a specific type of lung cancer that has not spread far, and you must have completed radiation and chemotherapy without the cancer getting worse.
You may have advanced or metastatic non-small cell lung cancer, which is lung cancer that has spread, provided it does not have specific genetic changes (EGFR/ALK wild-type) and you have already tried certain types of immune therapy and platinum-based chemotherapy.

Who cannot join the trial?

7 criteria

Having an active autoimmune disease, which is a condition where the body's immune system mistakenly attacks its own healthy cells, that requires medicine to be taken throughout the whole body.
Having an uncontrolled infection, such as HIV (a virus that attacks the immune system) or hepatitis B or C (viruses that cause liver inflammation), that is not currently managed.
Having brain metastases, which are areas where cancer has spread to the brain, that cause symptoms and are not being successfully managed by treatment.
Having previously used immune checkpoint inhibitors, which are a type of medicine that helps the immune system fight cancer, unless you are part of the specific group with advanced or spreading non-small cell lung cancer.
For those with hepatocellular carcinoma (a type of liver cancer): having hepatic encephalopathy, which is a brain problem caused by liver issues; uncontrolled ascites, which is a buildup of fluid in the belly; or active gastrointestinal bleeding, which is bleeding in the digestive tract.
For those with non-small cell lung cancer: having pneumonitis, which is inflammation of the lung tissue, or interstitial lung disease, which is a group of conditions that cause scarring in the lungs, that requires medicine to be taken throughout the whole body.
For those with limited stage small cell lung cancer: having extensive-stage disease, meaning the cancer has spread widely, or uncontrolled CNS metastases, which means cancer has spread to the central nervous system (the brain and spinal cord) and is not being managed.

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Verified sites

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

Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Verified
Lublin, Poland
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Verified
Przemysl, Poland

Trial locations

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Investigated drugs

Ceralasertib
is a medication taken by mouth as a tablet that is being tested in this study.
Tremelimumab
is a medication given through an intravenous infusion to help the body's immune system fight cancer.
Durvalumab
is a medication given through an intravenous infusion to help the body's immune system fight cancer.
Infliximab
is a medication given through an intravenous infusion used as a background treatment in this study.
Mycophenolate mofetil
is a medication taken by mouth used as a background treatment in this study.
AZD4773
is a combination therapy given as a subcutaneous injection (under the skin) that contains Durvalumab and Hyaluronidase to be tested in this study.

What is already known about the treatment

Ceralasertib
This medication is taken by mouth in the form of a film-coated tablet and is currently being studied in clinical trials for various types of cancer. It belongs to a class of drugs known as kinase inhibitors, which work by blocking specific proteins inside cancer cells to stop them from growing. This drug targets signaling pathways that help tumors survive and multiply.
Tremelimumab
This drug is administered through an intravenous infusion and is used as an immunotherapy to treat certain types of cancer. It belongs to a group called checkpoint inhibitors, which work by attaching to specific proteins on immune cells to help the body's natural defenses recognize and attack cancer cells. By removing the "brakes" from the immune system, it allows the body to fight the disease more effectively.
Durvalumab
This medication is given via intravenous infusion and is an approved immunotherapy used to treat several types of advanced lung cancer. As a checkpoint inhibitor, it works at a molecular level by blocking a protein called PD-L1, which cancer cells often use to hide from the immune system. This action helps the immune system regain its ability to identify and destroy cancer cells.
Infliximab
This drug is administered through an intravenous infusion and is an established medication used to treat various inflammatory conditions. It belongs to a class of drugs called monoclonal antibodies that work by blocking a specific protein in the body that causes inflammation. By targeting this protein, the drug helps reduce swelling and damage in the tissues.
Mycophenolate mofetil
This medication is taken orally and is commonly used to prevent the body from rejecting transplanted organs. It is classified as an immunosuppressant, which means it works by interfering with the production of certain white blood cells. By reducing the number of these cells, the drug helps prevent the immune system from attacking healthy tissue.
AZD4773
This is an experimental combination therapy administered through a subcutaneous injection, meaning it is injected just under the skin. It consists of durvalumab, an immunotherapy that helps the immune system find cancer, paired with hyaluronidase, an enzyme that helps the medication spread more easily through body tissues. This combination is being studied to improve how effectively the cancer treatment reaches its target.

Investigated diseases

Non-small cell lung cancer
This is a type of lung cancer that begins in the cells that make up the airways and lung tissue. It is the most common form of lung cancer and can be categorized into several subtypes. As it progresses, the cancer cells may grow into nearby tissues or spread to distant parts of the body. In some stages, the tumor cannot be easily removed through surgery.
Small cell lung cancer
This type of lung cancer starts in specific cells located in the lungs that are known to produce much smaller cells than other types. It is characterized by a rapid rate of growth and division. The disease often spreads quickly to other organs or lymph nodes after appearing. It is generally categorized by whether the cancer is confined to one area or has spread.
Hepatocellular carcinoma
This is a primary type of liver cancer that develops from the main cells in the liver. It often arises in people with existing liver damage or scarring. The disease progresses as abnormal cells multiply uncontrollably within the liver tissue. It can eventually involve larger areas of the liver or spread to other parts of the body.