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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland

Other Sites

Site Name City Country Status
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland
Wkmdsumqjg Sbmcnrv Ixf Slyzlfy Pbq W Payiumskz Przemysl Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Recruiting
25.05.2026

Trial locations

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.

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.

Trial ID:
2025-521639-34-00
Protocol code:
D907HC00001
Trial Phase:
Human Pharmacology (Phase I) – Other

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