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NCT07493304From ClinicalTrials.govRecruiting

Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers

A 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against Factor XI, for the Treatment and Secondary Prevention of Venous Thromboembolism in Participants With Solid and Hematologic Cancers (ROXI-CAT-II)

  • Venous Thromboembolism (VTE)

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Regeneron Pharmaceuticals
Enrolment target
1,600
Started
26 August 2026
Main results due
18 July 2031
Study sites
12
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Key Inclusion Criteria:

1. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 at the time of screening and day 1 prior to first dose of study intervention
2. In Part 1 participants with cancer and Part 2 participants: Histologically confirmed diagnosis of malignant solid or select hematologic tumor (other than basal-cell or squamous-cell carcinoma of the skin alone) as described in the protocol
3. Part 1 additional criteria:

   1. Has newly diagnosed symptomatic lower extremity DVT or incidentally-detected proximal lower extremity DVT (eg, popliteal or femoral) within 5 days (120 hours) of randomization (with imaging confirmation)
   2. Anticoagulation therapy with a therapeutic dose of a Direct Oral Anticoagulant (DOAC) for at least 3 months is indicated for the newly diagnosed proximal lower extremity DVT
4. Part 2 additional criteria:

   1. Newly diagnosed VTE within 5 days (120 hours) of randomization (with imaging confirmation) as described in the protocol
   2. Anticoagulation therapy with a therapeutic dose of a DOAC for at least 6 months is indicated for newly diagnosed VTE

Key Exclusion Criteria:

1. Is at high risk of intracranial bleeding in the opinion of the investigator
2. Known bleeding conditions (eg, Hemophilia A or B, von Willebrand's disease), hemorrhagic tumor sites, or other conditions with a high risk for bleeding (eg, hepatic disease associated with coagulopathy)
3. Contraindication to anticoagulation in the opinion of the investigator
4. Life expectancy of \< 6 months
5. Part 1 participants with cancer and Part 2 additional exclusion criteria:

   1. Has acute leukemia or myelodysplastic syndrome
   2. Has primary brain tumor
   3. Has brain metastases as described in the protocol
6. Part 1 additional exclusion criteria:

   1. Has a symptomatic PE
   2. Has an asymptomatic (incidentally-diagnosed) PE in a segmental or larger pulmonary artery
7. Part 2 additional exclusion criteria: PE leading to hemodynamic instability as described in the protocol

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

What this study is about

In the sponsor’s own words, from the registry.

This study is researching an experimental drug called REGN7508 (called "study drug") and will consist of 2 parts: Part 1 and Part 2. The study is focused on participants with or without cancer who develop blood clots in certain veins (called Deep Vein Thrombosis \[DVT\]) that block blood flow (Part 1) or focused on participants with cancer who develop blood clots in certain veins (DVT) or the lungs (also called Pulmonary Embolism \[PE\]) (Part 2).

The aim of the study is to see how safe and effective the study drug is at treating and preventing further blood clots in participants with or without cancer (Part 1) or in participants with cancer (Part 2) compared with another treatment (apixaban).

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Study sites(12)

  • Bioresearch Partner- Hialeah Hospital

    Hialeah, Florida, United States

    Withdrawn

  • Memorial Sloan Kettering Cancer Center

    New York, New York, United States

    Recruiting

  • El Paso Medical Research Institute (Medresearch Inc)

    El Paso, Texas, United States

    Withdrawn

  • Arensia Exploratory Medicine, Multiprofile Hospital for Active Treatment Sveta Sofia

    Sofia, Bulgaria

    Recruiting

  • Tokai University Hospital

    Isehara-Shi, Kanagawa, Japan

    Recruiting

  • Yamaguchi University Hospital

    Ube, Yamaguchi, Japan

    Recruiting

  • Institute of Oncology Bucharest

    Bucharest, Bucharest, Romania

    Recruiting

  • Arensia Exploratory Medicine, The Oncology Institute "Prof. Dr. Ion Chiricuta"

    Cluj-Napoca, Cluj, Romania

    Recruiting

  • Yonsei University Health System, Yongin Severance Hospital

    Yongin-si, Gyeonggi-do, South Korea

    Recruiting

  • Inje University, Haeundae Paik Hospital

    Busan, South Korea

    Recruiting

  • Yonsei University Health System, Severance Hospital

    Seoul, South Korea

    Recruiting

  • Samsung Medical Center

    Seoul, South Korea

    Recruiting

Showing 12 of 12 sites. 10 of the 12 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07493304. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hemato | Trialion