REGN7508 to prevent blood clots in adults with solid tumors
Official title: 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)
Run by Regeneron Pharmaceuticals · NCT07410117 · Data updated 2026-11-12
This study will test whether the experimental drug REGN7508 can prevent cancer-associated blood clots in adults with solid tumors who are receiving or about to start anticancer treatment or recovering from surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1120 (estimated) |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Locations | 28 sites (Hialeah, Florida and 27 other locations) |
| Status | Recruiting |
| Started | March 9, 2026 |
| Main results expected | January 23, 2030 |
| Study ends | May 6, 2030 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07410117 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically confirmed locally advanced or metastatic solid tumors, a Khorana score ≥2 or an agreed high-risk tumor genetic variant, ECOG 0–2, and who are receiving, about to start, or recovering from anticancer treatment are the intended participants.
✕Probably not a fit
Patients with high baseline bleeding risk (including bleeding disorders or hemorrhagic tumor sites), primary brain tumors or brain metastases, prior documented VTE/ATE, or cancers limited to basal or squamous cell skin carcinoma are excluded and unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 3, randomized, placebo-controlled study comparing REGN7508 to placebo for prevention of cancer-associated thrombosis in adults with locally advanced or metastatic solid tumors who are at increased clotting risk. Eligible participants have a Khorana score of 2 or greater or a tumor genetic variant linked to higher VTE risk and an ECOG performance status of 0–2. Participants receive REGN7508 or placebo while receiving anticancer therapy (or shortly before/after such therapy) and are monitored for new venous or arterial thromboembolic events, adverse events, drug levels in blood, and anti-drug antibodies. The trial is being conducted at multiple clinical research sites in the United States.
Why it matters
Potential benefit: If successful, REGN7508 could lower the risk of blood clots in high-risk cancer patients, potentially reducing complications and hospitalizations.
How similar studies have gone: Existing trials of anticoagulants such as LMWH and DOACs have shown benefit in reducing cancer-associated thrombosis, but REGN7508 is a novel investigational agent without established clinical evidence for CAT prevention.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Bioresearch Partner- Hialeah Hospital
Hialeah, Florida, United States Recruiting -
Helios Clinical Research
North Miami Beach, Florida, United States Recruiting -
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States Recruiting -
Memorial Sloan Kettering Cancer Center
New York, New York, United States Recruiting -
LTD High Technology Hospital Medcenter
Batumi, Adjara, Georgia Recruiting -
Krystyna Kiel Oncology Center
Kutaisi, Imereti, Georgia Recruiting
Show 22 more locations
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American Hospital Tbilisi
Tbilisi, Georgia Recruiting -
Israel Georgia Medical Research Clinic Helsicore
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 -
Ehime University Hospital
Tōon, Ehime, Japan Recruiting -
Gunma Prefectural Cancer Center
Ōta, Gunma, Japan 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 -
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan Recruiting -
Tohoku University Hospital
Sendai, Miyagi, Japan Recruiting -
National Hospital Organization Osaka National Hospital (ONH)
Chuo, Osaka, Japan Recruiting -
Saitama Cancer Center
Ina-machi, Saitama, Japan Recruiting -
National Cancer Center Hospital - Tsukiji Campus
Chuo Ku, Tokyo, Japan Recruiting -
Tokyo Medical University Hospital
Shinjuku, Tokyo, Japan Recruiting -
Yamaguchi University Hospital
Ube, Yamaguchi, Japan Recruiting -
Niigata University Medical & Dental Hospital
Niigata, Japan Recruiting -
El Paso Medical Research Institute (Medresearch Inc)
El Paso, Texas, United States Withdrawn
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.