This study aims to evaluate the efficacy and safety of REGN7508 for the prevention of Cancer-Associated Thrombosis, which refers to the formation of dangerous blood clots in people undergoing treatment for solid tumors. Blood clots can occur in the veins, such as Deep Vein Thrombosis, where a clot forms in a deep vein usually in the leg, or in the lungs, known as Pulmonary Embolism. Clots can also occur in the arteries, a condition called Arterial Thromboembolism. REGN7508 is a monoclonal antibody, a type of medicine designed to target a specific protein in the body called FXI to help prevent these clotting events.
Participants in this research will be randomly assigned to receive either REGN7508 or a placebo. This is a double-blind study, meaning that neither the participants nor the researchers know which treatment is being administered. During the course of the study, the effectiveness of the medication in preventing blood clots and its impact on the risk of bleeding will be monitored. This includes looking for any significant bleeding events to ensure the safety of the treatment.
Who Can Join the Study?
You must have a confirmed diagnosis of malignant solid tumors, which are non-healing growths of cancerous cells that are either spread to nearby areas or have moved to other parts of the body.
You must have a Khorana thromboembolic risk score of 2 or higher, which is a calculation used to predict how likely a person is to develop a blood clot.
Alternatively, you may join if you have a documented somatic tumor genetic variant, which means a specific change or mutation in the DNA of your tumor that is known to increase the risk of venous thromboembolism (VTE), a condition where blood clots form in the veins.
You must have an Eastern Cooperative Oncology Group (ECOG) Performance Status between 0 and 2, which is a scale used by doctors to measure how well you can perform daily activities and your overall physical strength during cancer treatment.
You can be either male or female.
You must fall within the specific age range defined for this study.
Who Cannot Join the Study?
You have known bleeding disorders, such as Hemophilia A or B or von Willebrand’s disease, which are conditions that prevent your blood from clotting properly.
You have hemorrhagic tumor sites, which means parts of your tumor are prone to bleeding.
You have conditions that put you at a high risk for bleeding, such as hepatic disease (liver disease) that is linked to coagulopathy (a problem with the blood’s ability to clot).
Your cancer is limited only to basal cell or squamous cell skin carcinoma, which are specific types of skin cancer.
You have a primary brain tumor (a tumor that started in the brain) or brain metastases (cancer that has spread to the brain from another part of the body).
You have a history of VTE (venous thromboembolism, which is a blood clot in a vein) or ATE (arterial thromboembolism, which is a blood clot in an artery).
You have had a blood clot that was found by accident during medical imaging and required anticoagulation (medicine used to prevent blood clots).
You have any other health condition that the study doctor believes might interfere with the study results or could put you at a higher risk of harm.
REGN7508 is a type of medicine called a monoclonal antibody. It is designed to target and block a specific protein in the blood called factor XI, which helps prevent the formation of dangerous blood clots in patients undergoing cancer treatment.
Cancer-associated thrombosis – This condition involves the formation of blood clots in people who have solid tumors. The presence of cancer can change how blood behaves, making it more likely to clump together. These clots can develop in the veins, known as deep vein thrombosis, or in the arteries. Over time, a clot may break loose and travel through the bloodstream to other parts of the body, such as the lungs. This process can lead to various types of blood clots depending on where they form.
The website uses cookies to ensure the proper functioning of the site and to analyze internet traffic. Some cookies are essential for using the service and do not require consent. You can accept all cookies or use only the essential ones. Data is processed in accordance with our Privacy Policy. You have the right to withdraw your consent, access, rectify, delete, or limit the processing of your data at any time.
Belgium 
Bulgaria 
Czechia 
France 
Germany 
Poland 
Romania 
Spain 
