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NCT07410117RecruitingPhase 3

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)

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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)

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1120 (estimated)
First submitted
6 Feb 2026
Start date
9 Mar 2026
Primary completion date
23 Jan 2030
Lead sponsor
Regeneron Pharmaceuticals
NCT number
NCT07410117
EU CT number
2024-519298-21-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1120
  • From 9 Mar 2026 to the primary completion date, 23 Jan 2030
  • 23 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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)
  • Has a cancer diagnosis consisting solely of basal cell or squamous cell skin carcinoma
  • 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

Other

  • Has a primary brain tumor or brain metastases as described in the protocol
  • Has proximal lower extremity DVT locally detected by Compression Ultrasound (CUS) during screening period

Who the study is looking for

  • Has a histologically confirmed diagnosis of malignant solid tumors which are locally advanced or metastatic as described in the protocol
  • 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
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
LTD High Technology Hospital Medcenter
Coordinator of this site? Confirm its status
BatumiGeorgiaRecruiting
Krystyna Kiel Oncology Center
Coordinator of this site? Confirm its status
KutaisiGeorgiaRecruiting
Institute of Clinical Oncology
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TbilisiGeorgiaRecruiting
Caucasus Medical Centre
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TbilisiGeorgiaRecruiting
American Hospital Tbilisi
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TbilisiGeorgiaRecruiting
Llc Todua Clinic
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TbilisiGeorgiaRecruiting
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Coordinator of this site? Confirm its status
TbilisiGeorgiaRecruiting
JSC Evex Hospitals - Caraps Medline
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TbilisiGeorgiaRecruiting
LTD Cancer Research Centre
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TbilisiGeorgiaRecruiting
Hyogo Cancer Center
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AkashiJapanRecruiting
National Hospital Organization Osaka National Hospital (ONH)
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ChuoJapanRecruiting
Saitama Cancer Center
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Ina-machiJapanRecruiting
Tokai University Hospital
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Isehara-ShiJapanRecruiting
Kagawa University Hospital
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Kita-gunJapanRecruiting
University Hospital Kyoto Prefectural University of Medicine
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KyotoJapanRecruiting
Niigata University Medical & Dental Hospital
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NiigataJapanRecruiting
Tokyo Medical University Hospital
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ShinjukuJapanRecruiting
Ehime University Hospital
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TōonJapanRecruiting
Yamaguchi University Hospital
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UbeJapanRecruiting
El Paso Medical Research Institute (Medresearch Inc)
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El PasoUnited StatesRecruiting
Bioresearch Partner- Hialeah Hospital
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HialeahUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
Helios Clinical Research
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North Miami BeachUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.