RecruitingPhase 3NCT07410117

REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis

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)


Sponsor

Regeneron Pharmaceuticals

Enrollment

860 participants

Start Date

Mar 9, 2026

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests REGN7508, a new drug being investigated to prevent dangerous blood clots (venous thromboembolism or VTE) in adults with advanced solid tumor cancers, who are at higher risk for clotting due to their cancer or its treatment. **You may be eligible if...** - You are an adult with a confirmed advanced or metastatic solid tumor cancer - You have a moderate-to-high clotting risk score (Khorana score of 2 or above) OR a genetic mutation in your tumor known to raise clotting risk - Your overall health is acceptable (ECOG 0-2) **You may NOT be eligible if...** - You have a known bleeding disorder (such as hemophilia or von Willebrand disease) or a high bleeding risk - Your cancer is only a skin cancer (basal cell or squamous cell) - You have a brain tumor or brain metastases - You have a history of blood clots (VTE or ATE) that required anticoagulation - You have any condition that could confound the results or put you at greater risk Talk to your doctor to see if this trial is right for you.

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

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT07410117