NCT07410117

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 860 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Cancer-Associated Thrombosis (CAT)

Interventions

Type	Name	Description
DRUG	REGN7508	Administered per the protocol
DRUG	Placebo	Administered per the protocol

Timeline

• Start date: 2026-03-09
• Primary completion: 2030-01-23
• Completion: 2030-05-06
• First posted: 2026-02-13
• Last updated: 2026-04-09

Locations

12 sites across 2 countries: United States, Georgia

Regulatory

• FDA-regulated drug study