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
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LTD High Technology Hospital Medcenter Coordinator of this site? Confirm its status | Batumi | Georgia | Recruiting |
| Krystyna Kiel Oncology Center Coordinator of this site? Confirm its status | Kutaisi | Georgia | Recruiting |
| Institute of Clinical Oncology Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Caucasus Medical Centre Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| American Hospital Tbilisi Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Llc Todua Clinic Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| JSC Evex Hospitals - Caraps Medline Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| LTD Cancer Research Centre Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Hyogo Cancer Center Coordinator of this site? Confirm its status | Akashi | Japan | Recruiting |
| National Hospital Organization Osaka National Hospital (ONH) Coordinator of this site? Confirm its status | Chuo | Japan | Recruiting |
| Saitama Cancer Center Coordinator of this site? Confirm its status | Ina-machi | Japan | Recruiting |
| Tokai University Hospital Coordinator of this site? Confirm its status | Isehara-Shi | Japan | Recruiting |
| Kagawa University Hospital Coordinator of this site? Confirm its status | Kita-gun | Japan | Recruiting |
| University Hospital Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Recruiting |
| Niigata University Medical & Dental Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Recruiting |
| Tokyo Medical University Hospital Coordinator of this site? Confirm its status | Shinjuku | Japan | Recruiting |
| Ehime University Hospital Coordinator of this site? Confirm its status | Tōon | Japan | Recruiting |
| Yamaguchi University Hospital Coordinator of this site? Confirm its status | Ube | Japan | Recruiting |
| El Paso Medical Research Institute (Medresearch Inc) Coordinator of this site? Confirm its status | El Paso | United States | Recruiting |
| Bioresearch Partner- Hialeah Hospital Coordinator of this site? Confirm its status | Hialeah | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Helios Clinical Research Coordinator of this site? Confirm its status | North Miami Beach | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.