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RecruitingInterventionalPhase 3

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)

NCT ID: NCT07410117Sponsor: Regeneron PharmaceuticalsLast updated: 2026-05-27

Summary

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)

Arms & interventions

  • DrugREGN7508

    Administered per the protocol

  • DrugPlacebo

    Administered per the protocol

Outcome measures

Primary

  • Time-to-first event of centrally adjudicated VTE (DVT, PE) or ATE, or thromboembolism- or ATE-related death

    Time frame: Through 6 months

  • Time-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH) major bleeding or Clinically Relevant Non-Major (CRNM) bleeding

    Time frame: Through 6 months

Secondary

  • Time-to-first event of the centrally adjudicated symptomatic or incidental VTE (DVT, PE) or ATE and thromboembolism- or ATE-related death

    Time frame: Through 6 months

  • Time-to-first event of symptomatic VTE

    Time frame: Through 6 months

  • Time-to-first event of symptomatic DVT

    Time frame: Through 6 months

  • Time-to-first event of symptomatic non-fatal PE

    Time frame: Through 6 months

  • Time-to-first event of thromboembolism-related death

    Time frame: Through 6 months

  • Time-to-first event of incidental VTE

    Time frame: Through 6 months

  • Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT

    Time frame: Through 6 months

  • Time-to-first event of incidental non-fatal PE (in a segmental or larger pulmonary artery)

    Time frame: Through 6 months

  • Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by lower extremities ultrasound)

    Time frame: Through 6 months

  • Time-to-first event of ATE

    Time frame: Through 6 months

  • Time-to-first event of ATE-related death

    Time frame: Through 6 months

  • Time-to-first event of centrally adjudicated VTE (DVT, PE), or thromboembolism-related death

    Time frame: Through 6 months

  • Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to day 245

  • Severity of TEAEs

    Time frame: Up to day 245

  • Occurrence of Anti-Drug Antibody (ADA) to REGN7508

    Time frame: Up to day 245

  • Magnitude of ADA to REGN7508

    Time frame: Up to day 245

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (3)

Bioresearch Partner- Hialeah Hospital

Hialeah, Florida, 33013

Recruiting

Helios Clinical Research

North Miami Beach, Florida, 33169

Recruiting

El Paso Medical Research Institute (Medresearch Inc)

El Paso, Texas, 79902

Recruiting