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REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Sponsor: Regeneron Pharmaceuticals
Summary
This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on the prevention of Cancer-Associated Thrombosis (CAT) in participants. The aim of the study is to see how effective the study drug is in preventing blood clots in participants with solid tumors who are currently receiving anticancer treatment or planning to start anticancer treatment within a month of being assigned to a study treatment, or recovering from surgery, and how the study drug compares to placebo for CAT. 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 study drug less effective or could lead to side effects)
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against FXI, for Primary Prophylaxis of Cancer-Associated Thrombosis for Participants With Solid Tumors Undergoing Cancer Treatment (ROXI-CAT-I)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
860
Start Date
2026-03-09
Completion Date
2030-05-06
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
REGN7508
Administered per the protocol
Placebo
Administered per the protocol
Locations (12)
Bioresearch Partner- Hialeah Hospital
Hialeah, Florida, United States
Helios Clinical Research
North Miami Beach, Florida, United States
El Paso Medical Research Institute (Medresearch Inc)
El Paso, Texas, United States
LTD High Technology Hospital Medcenter
Batumi, Adjara, Georgia
Krystyna Kiel Oncology Center
Kutaisi, Imereti, Georgia
American Hospital Tbilisi
Tbilisi, Georgia
Llc Todua Clinic
Tbilisi, Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, Georgia
Institute of Clinical Oncology
Tbilisi, Georgia
JSC Evex Hospitals - Caraps Medline
Tbilisi, Georgia
LTD Cancer Research Centre
Tbilisi, Georgia
Caucasus Medical Centre
Tbilisi, Georgia