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REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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)

NCT07410117•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)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 at the time of screening or harbors a somatic documented tumor genetic variant known to be associated with an 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

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 a history of objective evidence of VTE or ATE, including incidental VTE identified by diagnostic imaging requiring anticoagulation
•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

Locations (5)

Bioresearch Partner- Hialeah Hospital

Hialeah, Florida, United States

El Paso Medical Research Institute (Medresearch Inc)

El Paso, Texas, United States

LTD High Technology Hospital Medcenter

Batumi, Adjara, Georgia

Llc Todua Clinic

Tbilisi, Georgia

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Tbilisi, Georgia

Key Dates

Start Date

March 9, 2026

Primary Completion Date

January 23, 2030

Completion Date

May 6, 2030

Last Updated

March 18, 2026

Enrollment

860

ESTIMATED participants

Conditions

Cancer-Associated Thrombosis (CAT)

Interventions

REGN7508

DRUG

Placebo

DRUG

Contacts

Clinical Trials Administrator

CONTACT

844-734-6643 clinicaltrials@regeneron.com