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Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Sponsor: Regeneron Pharmaceuticals
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)
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1600
Start Date
2026-08-26
Completion Date
2031-07-18
Last Updated
2026-09-28
Healthy Volunteers
No
Conditions
Interventions
REGN7508
Administered per the protocol
Apixaban
Administered per the protocol
Locations (12)
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
Arensia Exploratory Medicine, Multiprofile Hospital for Active Treatment Sveta Sofia
Sofia, Bulgaria
Tokai University Hospital
Isehara-Shi, Kanagawa, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Institute of Oncology Bucharest
Bucharest, Bucharest, Romania
Arensia Exploratory Medicine, The Oncology Institute "Prof. Dr. Ion Chiricuta"
Cluj-Napoca, Cluj, Romania
Yonsei University Health System, Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea
Inje University, Haeundae Paik Hospital
Busan, South Korea
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea