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A study to evaluate the effectiveness of REGN7508 for preventing blood clots in adults with solid tumors undergoing cancer treatment.

Fast replyInvestigationalNo placebo
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What is this trial about?

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

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    You will receive either the test medication, known as regn7508, or a placebo, which is an inactive substance that looks like the medication but contains no medicine.

    The purpose of this study is to determine if regn7508, a type of protein designed to target factor XI (a substance in the blood that helps clotting), can prevent cancer-associated thrombosis. cancer-associated thrombosis is the formation of blood clots in people undergoing treatment for solid tumors.

  2. Step 2

    Monitoring for blood clots and bleeding

    The study focuses on tracking the time until the first occurrence of certain blood clot events, such as deep vein thrombosis (a clot in a deep vein, usually in the leg), pulmonary embolism (a clot that travels to the lungs), or arterial thromboembolism (a clot in an artery).

    The study also monitors for bleeding events, including major bleeding or clinically relevant non-major bleeding, to ensure safety.

  3. Step 3

    Safety and side effect assessment

    The occurrence and severity of any adverse events, which are side effects or medical problems that happen during the treatment, will be recorded.

    The presence of anti-drug antibodies, which are proteins the body might create in response to the medication, will be measured.

Who can join the trial?

6 criteria

  • 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 trial?

8 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

REGN7508 - This medication is an experimental monoclonal antibody that is administered through an injection. Currently being studied in clinical trials, it is being investigated as a way to prevent blood clots in patients undergoing treatment for solid tumors. It works at a molecular level by targeting and blocking a specific protein called Factor XI, which helps stop the blood clotting process without significantly increasing the risk of bleeding. This substance is classified as a targeted biologic therapy designed for the prevention of cancer-associated blood clots.

Investigated diseases

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.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519298-21-00Protocol codeR7508-CAT-2392Estimated enrolment860 patientsSponsorRegeneron Pharmaceuticals Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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