RecruitingPhase 3NCT07493304

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)


Sponsor

Regeneron Pharmaceuticals

Enrollment

1,600 participants

Start Date

Aug 31, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Apixaban and a drug called REGN7508 for people with venous thromboembolism (vte). The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGREGN7508

Administered per the protocol

DRUGApixaban

Administered per the protocol


Locations(6)

Bioresearch Partner- Hialeah Hospital

Hialeah, Florida, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

El Paso Medical Research Institute (Medresearch Inc)

El Paso, Texas, United States

Yongin Severance Hospital

Yongin-si, Gyeonggi-do, South Korea

Haeundae Paik Hospital

Pusan, Gyeongsangnam-do, South Korea

Severance Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT07493304


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