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Study on Abelacimab and Dalteparin for Preventing Blood Clots in Patients with Gastrointestinal or Genitourinary Cancer

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 clinical trial is focused on studying a condition known as venous thromboembolism (VTE), which is a type of blood clot that can occur in patients with certain types of cancer, specifically gastrointestinal (GI) and genitourinary (GU) cancer. The study is comparing two treatments: Abelacimab, a new medication given as a solution for infusion, and Fragmin® (dalteparin sodium), a solution for injection that is already used to treat VTE. The purpose of the study is to see if Abelacimab is as effective as Fragmin® in preventing the recurrence of VTE in these patients.

Participants in the study will receive either Abelacimab or Fragmin® for a period of six months. The study is designed to monitor the recurrence of VTE and any bleeding events during this time. Abelacimab is administered through a method called subcutaneous use, which means it is injected under the skin. Similarly, Fragmin® is also given through subcutaneous injection. The study aims to determine if Abelacimab can prevent VTE recurrence as effectively as Fragmin® and, if successful, to see if it might be even better.

Throughout the study, participants will be closely monitored to track any occurrences of VTE and to ensure their safety. The study is open-label, meaning that both the participants and the researchers know which treatment is being administered. However, the evaluation of the study's outcomes is blinded, meaning that the people assessing the results do not know which treatment the participants received, to ensure unbiased results. The study is expected to continue until 2025, providing valuable information on the effectiveness of Abelacimab in treating VTE in patients with GI or GU cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, type of cancer, and recent diagnosis of venous thromboembolism (VTE).

    Written informed consent is required to participate.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either abelacimab or dalteparin sodium.

    This process ensures that each participant has an equal chance of receiving either treatment.

  3. Step 3

    Treatment administration

    If assigned to abelacimab, the medication is administered as a 150 mg/ml solution for infusion, given subcutaneously.

    If assigned to dalteparin sodium (Fragmin® 5000 IU), it is administered as a solution for injection, also given subcutaneously.

    The treatment continues for a duration of 6 months.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, participants are monitored for any recurrence of VTE and any bleeding events.

    The primary endpoint is the time to the first event of centrally adjudicated VTE recurrence within 6 months post-randomization.

  5. Step 5

    Completion of study

    The study is estimated to conclude by September 1, 2025.

    Upon completion, data from the study will be analyzed to determine the effectiveness of abelacimab compared to dalteparin sodium in preventing VTE recurrence.

Who can join the trial?

5 criteria

  • Participants must be **male or female** and at least **18 years old** or the legal age of maturity in their country.
  • Participants must have a confirmed diagnosis of **gastrointestinal (GI)** or **genitourinary (GU) cancer**. This includes cancers of the colon, pancreas, stomach, esophagus, liver, kidneys, bladder, prostate, or urethra. The cancer must be either not removable by surgery, locally advanced, spread to other parts of the body, or not spread but with no planned surgery to cure it during the study.
  • Participants must have a confirmed **deep vein thrombosis (DVT)** in the upper part of the leg or a **pulmonary embolism (PE)**, which is a blood clot in the lung. This can be either a clot causing symptoms or one found by chance. Participants must join the study within **120 hours** (5 days) of being diagnosed with the blood clot.
  • Participants must need **anticoagulation therapy** with a type of medication called **low molecular weight heparin (LMWH)** for at least **6 months**.
  • Participants must be able to provide **written informed consent**, which means they understand the study and agree to take part.

Who cannot join the trial?

8 criteria

  • Patients who do not have **gastrointestinal** (related to the stomach and intestines) or **genitourinary** (related to the genital and urinary organs) cancer.
  • Patients who have not been recently diagnosed with **venous thromboembolism (VTE)**, which is a condition where blood clots form in the veins.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who have other medical conditions that might interfere with the study or make participation unsafe.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have a history of allergic reactions to the study medications.
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Investigated drugs

  • Abelacimab

    is a medication being studied to see if it can prevent blood clots from coming back in patients who have certain types of cancer, specifically gastrointestinal or genitourinary cancer. The study is looking at how well abelacimab works compared to another medication, focusing on its ability to stop blood clots without causing too much bleeding.

  • Dalteparin

    is a medication that is already used to prevent and treat blood clots. In this study, it is being used as a comparison to see if abelacimab is as effective or better at preventing blood clots in patients with specific types of cancer. The goal is to see if abelacimab can provide the same benefits as dalteparin with fewer side effects.

What is already known about the treatment

  • Abelacimab

    Abelacimab is administered via injection and is currently being studied in clinical trials for its effectiveness in preventing venous thromboembolism (VTE) recurrence in patients with gastrointestinal or genitourinary cancer. It is in the phase 3 stage of clinical trials, where its efficacy is being compared to dalteparin. Abelacimab works by inhibiting Factor XI, a protein involved in the blood clotting process, thereby reducing the risk of clot formation. It is classified as an anticoagulant medication.

  • Dalteparin

    Dalteparin is administered through subcutaneous injection and is an established medication used to prevent and treat venous thromboembolism (VTE), particularly in patients with cancer. It is a low molecular weight heparin that works by enhancing the activity of antithrombin, a protein that inhibits blood clotting factors, thus preventing clot formation. Dalteparin is widely recognized in medical literature and is classified as an anticoagulant.

Investigated diseases

Venous Thromboembolism (VTE) – This condition involves the formation of blood clots in the veins, which can lead to complications if the clots travel to the lungs, causing a pulmonary embolism. VTE often occurs in the deep veins of the legs, known as deep vein thrombosis (DVT). In patients with gastrointestinal or genitourinary cancer, the risk of developing VTE is increased due to factors like immobility, cancer treatments, and the cancer itself. The progression of VTE can vary, with some individuals experiencing mild symptoms, while others may have significant swelling, pain, or redness in the affected area. If not managed, VTE can lead to further complications, including chronic pain and swelling in the legs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-513992-42-00Protocol codeANT-008Estimated enrolment1 033 patientsSponsorAnthos Therapeutics Inc.

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