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Clinical trials

A ‘clinical trial’ is a research study in which people agree to test a potential new treatment to prevent or improve a disease or medical condition. A clinical trial also looks at how participants react to the potential new treatment and if any unwanted effects occur. This helps to determine if the new investigational treatment works, is safe, and is better than those that are already available. Many clinical trials also compare existing treatments or test new ways to use or combine existing treatments.

A.

Clinical Trial of Debio 0123 as monotherapy

Cancer cells generally grow quickly and accumulate DNA damage over time. Too much DNA damage could cause the cells to die when they divide to form new cells. Therefore, many cancer cells take advantage of cell machinery, which allows time to repair this damage, so they can continue to multiply and survive.  

The drug being investigated in this study, Debio 0123, prevents the cells from repairing their damaged DNA. In this way, it is believed that it may help to kill cancer cells and reduce tumor size. 

Debiopharm international is conducting a phase 1 dose-finding and dose-expansion study evaluating the safety, tolerability, pharmacokinetics, and efficacy of a highly selective WEE1 inhibitor (Debio 0123) administered orally in adult patients with advanced solid tumors. Patients eligible for this study must have a good general condition (ECOG performance status 0–1), with diagnosis of locally advanced or metastatic solid tumor for which prior standard therapies have failed or not available therapy of proven efficacy is available. Patients with active second tumors who have required treatment in the last 6 months or with unstable brain metastases are not eligible for this study. Other details about the eligibility for this study could be consulted in clinicaltrials.gov.  

The purpose of this trial is to determine the maximum dose of Debio 0123 that it is tolerated and to select the dose to be used in future trials. In addition, the purpose of the study is to characterize the safety profile and tolerability of Debio 0123 at the selected dose, and to evaluate the preliminary activity of Debio 0123 as monotherapy against tumor cells in different types of cancer.   

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B.

Talk with your medical doctor

If you are interested in participating in an upcoming clinical trial, ask your doctor if a clinical trial might be right for you. Your doctor knows both you and your health history, which is invaluable in making this decision. Your doctor can help you gather the information needed to locate a trial and help you identify what questions might be important to ask before deciding to participate. When you join a clinical trial, you will still receive care from your primary doctor for your overall health. Most trials are only for a limited time and only pertain to the condition being studied. 

C.

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A.

Clinical trial of Debio 1143 with nivolumab in specific advanced solid tumors

Debiopharm International is conducting an open-label two-part Phase 1b/2 trial in male and female patients with either small cell lung cancer, squamous cell carcinoma of the head and neck, selected gastrointestinal or gynecologic cancers with specific genetic alterations. Tumors with these genetic alterations may respond better to this study treatment. To be eligible, patients must have received at least one prior standard chemotherapy or have no established standard therapeutic alternatives. In addition, patients must have progressed during prior immuno-oncology treatment.

The purpose of Part B is to evaluate whether Debio 1143 combined with nivolumab leads to efficient shrinkage of the tumor in patients with different types of cancer and to determine how safe it is.

Debio 1143 is an investigational medicinal product. Nivolumab is a monoclonal antibody that specifically blocks a target in the body called PD-1 and stimulates the immune system to fight cancer cells.

Debio 1143 is administered orally once daily for 10 consecutive days every 2 weeks. Nivolumab is administered by infusion every 2 weeks.

  • _Phases

    • P
    • M
B.

Talk with your medical doctor

If you are interested in participating in an upcoming clinical trial, ask your doctor if a clinical trial might be right for you. Your doctor knows both you and your health history, which is invaluable in making this decision. Your doctor can help you gather the information needed to locate a trial and help you identify what questions might be important to ask before deciding to participate. When you join a clinical trial, you will still receive care from your primary doctor for your overall health. Most trials are only for a limited time and only pertain to the condition being studied.

C.

Find the trials on the map

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Please accept them in order to show the map.

Manage Cookies

A.

Clinical trial of Debio 1143 combined with avelumab in advanced or metastatic non-small cell lung cancer

Debiopharm International is conducting an open-label Definition An open-label trial means that no placebo is administered and that patients know what treatment they are given. two-part Phase I trial in male and female patients. Part A is enrolling patients with advanced solid malignancies and Part B is aimed at patients with advanced or metastatic non-small cell lung cancer having already received platinum-based therapy.

The purpose of Part A is to evaluate increasing doses of Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of apoptosis proteins (IAPs) by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK combined with avelumab in patients with various advanced solid malignancies to determine the best tolerated dose that can be given to patients in Part B with advanced or metastatic non-small cell lung cancer. Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of apoptosis proteins (IAPs) by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK is an investigational medicinal product. Avelumab is a monoclonal antibody (a type of protein) that specifically attaches and blocks a target in the body call PD-L1, thus preventing cancer cells to evade the host (or patient) normal immune response.

In Part A, Debio 1143 Definition Debio 1143 is a small molecule that neutralizes inhibitor of apoptosis proteins (IAPs) by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).Debio 1143 aims to improve cancer patient treatment outcomes by sensitizing cancer cells to the action of chemotherapy, radiotherapy, and/or immune checkpoint inhibitors. Debio 1143 is a potent orally available IAP inhibitor currently in development in Head and Neck, Ovarian and advanced solid tumors. For more info: http://bit.ly/2xa7RUK is administered orally once daily for 10 consecutive days every 2 weeks. Avelumab is administered by infusion twice every cycle.

  • _Phases

    • P
    • M
B.

Talk with your medical doctor

If you are interested in participating in an upcoming clinical trial, ask your doctor if a clinical trial might be right for you. Your doctor knows both you and your health history, which is invaluable in making this decision. Your doctor can help you gather the information needed to locate a trial and help you identify what questions might be important to ask before deciding to participate. When you join a clinical trial, you will still receive care from your primary doctor for your overall health. Most trials are only for a limited time and only pertain to the condition being studied.

C.

Find the trials on the map

This map relies on Google Maps, which could install cookies.
Please accept them in order to show the map.

Manage Cookies

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