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NCT Number: NCT07410117

REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis

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)

Recruiting

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Key information

Conditions

Cancer-Associated Thrombosis (CAT) Cardiovascular Diseases Embolism Embolism and Thrombosis Hemorrhage Lung Diseases Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

LTD High Technology Hospital Medcenter, Batumi, Adjara, Georgia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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 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
  • 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

Treatment and study plan

REGN7508

Drug

Administered per the protocol

Other names: cenvacibart

Placebo

Drug

Administered per the protocol

Primary outcomes

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

    Time frame: Through 6 months

  2. 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 outcomes

  1. 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

  2. Time-to-first event of symptomatic VTE

    Time frame: Through 6 months

  3. Time-to-first event of symptomatic DVT

    Time frame: Through 6 months

  4. Time-to-first event of symptomatic non-fatal PE

    Time frame: Through 6 months

  5. Time-to-first event of thromboembolism-related death

    Time frame: Through 6 months

  6. Time-to-first event of incidental VTE

    Time frame: Through 6 months

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

    Time frame: Through 6 months

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

    Time frame: Through 6 months

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

    Time frame: Through 6 months

  10. Time-to-first event of ATE

    Time frame: Through 6 months

  11. Time-to-first event of ATE-related death

    Time frame: Through 6 months

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

    Time frame: Through 6 months

  13. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to day 245

  14. Severity of TEAEs

    Time frame: Up to day 245

  15. Occurrence of Anti-Drug Antibody (ADA) to REGN7508

    Time frame: Up to day 245

  16. Magnitude of ADA to REGN7508

    Time frame: Up to day 245

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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)

Acronym: ROXI-CAT-I

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 13, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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