NCT07410117From ClinicalTrials.govRecruiting

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)

Cancer-Associated Thrombosis (CAT)

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Regeneron Pharmaceuticals
Enrolment target: 1,120
Started: 9 March 2026
Main results due: 23 January 2030
Study sites: 20
Registry updated: 29 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Key Inclusion Criteria:

1. Has a histologically confirmed diagnosis of malignant solid tumors which are locally advanced or metastatic as described in the protocol
2. Has a Khorana thromboembolic risk score ≥2 during screening period or harbors a somatic documented tumor genetic variant known to be associated with a similar increased risk of VTE as described in the protocol
3. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 at the time of screening and day 1 prior to the first dose of study intervention

Key Exclusion Criteria:

1. Has known bleeding conditions (eg, Hemophilia A or B, von Willebrand's disease), hemorrhagic tumor sites, or other conditions with a high risk for bleeding (eg, hepatic disease associated with coagulopathy)
2. Has a cancer diagnosis consisting solely of basal cell or squamous cell skin carcinoma
3. Has a primary brain tumor or brain metastases as described in the protocol
4. Has proximal lower extremity DVT locally detected by Compression Ultrasound (CUS) during screening period
5. Has any condition that, as judged by the investigator, may confound the results of the study or would place the participant at increased risk of harm if he/she participated in the study

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

What this study is about

In the sponsor’s own words, from the registry.

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)

Study sites(20)

Bioresearch Partner- Hialeah Hospital
Hialeah, Florida, United States
Recruiting
Helios Clinical Research
North Miami Beach, Florida, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
El Paso Medical Research Institute (Medresearch Inc)
El Paso, Texas, United States
Recruiting
LTD High Technology Hospital Medcenter
Batumi, Adjara, Georgia
Recruiting
Krystyna Kiel Oncology Center
Kutaisi, Imereti, Georgia
Recruiting
American Hospital Tbilisi
Tbilisi, Georgia
Recruiting
Llc Todua Clinic
Tbilisi, Georgia
Recruiting
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, Georgia
Recruiting
Institute of Clinical Oncology
Tbilisi, Georgia
Recruiting
JSC Evex Hospitals - Caraps Medline
Tbilisi, Georgia
Recruiting
LTD Cancer Research Centre
Tbilisi, Georgia
Recruiting
Caucasus Medical Centre
Tbilisi, Georgia
Recruiting
Hyogo Cancer Center
Akashi, Hyōgo, Japan
Recruiting
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
Recruiting
Tokai University Hospital
Isehara-Shi, Kanagawa, Japan
Recruiting
National Hospital Organization Osaka National Hospital (ONH)
Chuo, Osaka, Japan
Recruiting
Saitama Cancer Center
Ina-machi, Saitama, Japan
Recruiting
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Recruiting
Niigata University Medical & Dental Hospital
Niigata, Japan
Recruiting

Showing 20 of 20 sites. 20 of the 20 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07410117. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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