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REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis

Study acronym: ROXI-CAT-I
StatusRecruiting
PhasePhase 3
Started2026-03-09
View on ClinicalTrials.gov ↗

Amendment history

2026-08-18
Study Status, Contacts/Locations v5
Trial sites expanded: 14 → 20 locations
2026-07-21
Study Status, Contacts/Locations v4
Study sites12→13
2026-05-22
Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility v3
Primary endpoint(s) modified2 entries, revised
WasTime-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH) major bleeding or Clinically Relevant Non-Major (CRNM) bleeding, Time-to-first event of centrally adjudicated VTE [Deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE) or Arterial thromboembolism (ATE), or thromboembolism- or ATE-related death]
NowTime-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH) major bleeding or Clinically Relevant Non-Major (CRNM) bleeding, Time-to-first event of centrally adjudicated VTE (DVT, PE) or ATE, or thromboembolism- or ATE-related death
Enrollment increased: 860 → 1120 participants
Eligibility criteria-23 characters
[...] in the protocol Has a Khorana thromboembolic risk score ≥2 at the time ofduring screening period or harbors a somatic documented tumor genetic variant known to be associated with ana similar increased risk of VTE as described in the protocol Has an E [...] tumor or brain metastases as described in the protocol Has aproximal historylower ofextremity objectiveDVT evidencelocally of VTE or ATE, including incidental VTE identifieddetected by diagnosticCompression imagingUltrasound requiring(CUS) anticoagulationduring screening period Has any condition that, as judged by the investigator, may [...]
Secondary endpoints8 to 16 entries
Time-to-first event of DVTthe (centrally adjudicated symptomatic or asymptomaticincidental [VTE (DVT, PE) or ATE and thromboembolism- or ATE-related death Time-to-first event of symptomatic VTE Time-to-first event of symptomatic DVT Time-to-first event of symptomatic non-fatal PE Time-to-first event of thromboembolism-related death Time-to-first event of incidental VTE Time-to-first event [...] proximal] lower extremity DVT Time-to-first event of incidental non-fatal PE (in a segmental or larger pulmonary artery) Time-to-first event of non-fatalasymptomatic PEVTE (symptomaticAsymptomatic orDVT asymp [...] [...]
2026-04-08
Study Status, Contacts/Locations v2
Trial sites expanded: 5 → 12 locations
2026-03-16
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2029-07-21→2030-01-23
Completion date2029-11-01→2030-05-06
Start dateestimated 2026-02-16→confirmed 2026-03-09
Study sites0→5
2026-02-12
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
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)
Trial Details
NCT Number NCT07410117
Lead Sponsor Regeneron Pharmaceuticals
Conditions Cancer-Associated Thrombosis (CAT)
Enrollment 1,120 participants
Start Date 2026-03-09
Primary Completion 2030-01-23 (estimated)
Study Completion 2030-05-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-29