REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis

NCT07410117
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,120
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Lead sponsor
Regeneron Pharmaceuticals
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Start date
2026-03-09
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Number of sites
14
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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)
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Acronym
ROXI-CAT-I
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Short title
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
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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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2030-05-06
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First posted
2026-02-13
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Registry last updated
2026-08-20
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Primary completion date
2030-01-23
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Start date
2026-03-09
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Participants
1,120
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Participant count basis
Estimated
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Planned participants
1,120
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Protocol amendments
1
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Number of sites
14
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Regeneron Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07410117
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ClinicalTrials.gov ID
NCT07410117
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: 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

    Timeframe: Through 6 months

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

    Timeframe: Through 6 months

  2. Time-to-first event of symptomatic VTE

    Timeframe: Through 6 months

  3. Time-to-first event of symptomatic DVT

    Timeframe: Through 6 months

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

    Timeframe: Through 6 months

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

    Timeframe: Through 6 months

  6. Time-to-first event of incidental VTE

    Timeframe: Through 6 months

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

    Timeframe: Through 6 months

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

    Timeframe: Through 6 months

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

    Timeframe: Through 6 months

  10. Time-to-first event of ATE

    Timeframe: Through 6 months

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

    Timeframe: Through 6 months

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

    Timeframe: Through 6 months

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

    Timeframe: Up to day 245

  14. Severity of TEAEs

    Timeframe: Up to day 245

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

    Timeframe: Up to day 245

  16. Magnitude of ADA to REGN7508

    Timeframe: Up to day 245

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy 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

Sources for eligibility
clinicaltrials.gov

  • Bioresearch Partner- Hialeah HospitalHialeah, United StatesRecruiting
  • Helios Clinical ResearchNorth Miami Beach, United StatesRecruiting
  • El Paso Medical Research Institute (Medresearch Inc)El Paso, United StatesRecruiting
  • LTD High Technology Hospital MedcenterBatumi, GeorgiaRecruiting
  • Krystyna Kiel Oncology CenterKutaisi, GeorgiaRecruiting
  • American Hospital TbilisiTbilisi, GeorgiaRecruiting
  • Llc Todua ClinicTbilisi, GeorgiaRecruiting
  • Tbilisi State Medical University and Ingorokva High Medical Technology University ClinicTbilisi, GeorgiaRecruiting
  • Institute of Clinical OncologyTbilisi, GeorgiaRecruiting
  • JSC Evex Hospitals - Caraps MedlineTbilisi, GeorgiaRecruiting
  • LTD Cancer Research CentreTbilisi, GeorgiaRecruiting
  • Caucasus Medical CentreTbilisi, GeorgiaRecruiting
  • Yamaguchi University HospitalUbe, JapanRecruiting
  • Niigata University Medical & Dental HospitalNiigata, JapanRecruiting
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-519298-21-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (4)

Targets (2)