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RECRUITING
NCT07410117
PHASE3

REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

REGN7508

Administered per the protocol

DRUG

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