Clinical trial Recruiting at 27 sites Phase 3 Interventional Ages 18 and up

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

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment1120 (estimated)
SponsorRegeneron Pharmaceuticals
Industry-sponsored
Locations28 sites (Hialeah, Florida and 27 other locations)
StatusRecruiting
StartedMarch 9, 2026
Main results expectedJanuary 23, 2030
Study endsMay 6, 2030
Registry record updatedNovember 5, 2026
Trial IDNCT07410117 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

  • 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
  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.