> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/regn7508-in-adult-participants-for-prevention-of-cancer-0fbf889e-f664-41aa-a894-bd6a26ad0c11 > Record changed: 2026-10-13 # REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis NCT07410117 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) Participants 1,120 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) Lead sponsor Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) Start date 2026-03-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) Number of sites 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) ## Title and summary **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Acronym** ROXI-CAT-I Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Short title** REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) ## Dates **Completion date** 2030-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **First posted** 2026-02-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Registry last updated** 2026-08-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Primary completion date** 2030-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Start date** 2026-03-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) ## Size and sites **Participants** 1,120 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Planned participants** 1,120 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Number of sites** 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Lead sponsor** Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) ## Identifiers **Registry ID** NCT07410117 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **ClinicalTrials.gov ID** NCT07410117 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) ## Outcomes ### Primary outcomes 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 ### 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 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) ## Eligibility **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) ## References ### Other registry identifiers - 2024-519298-21-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410117) ## Related records ### Drugs (1) - [Onasemnogene abeparvovec](https://trialight.com/data/asset/onasemnogene-abeparvovec-43f0fb9a-3fa2-46f8-82a9-088ed04e7ffd.md) ### Lead sponsors (1) - [Regeneron Pharmaceuticals](https://trialight.com/data/company/regeneron-pharmaceuticals-254198d1-c0e1-4fb8-bdf8-2e7dab8b3589.md) ### Conditions (4) - [Pulmonary embolism](https://trialight.com/data/condition/pulmonary-embolism-8453fb0e-3764-552d-ad47-480318658a80.md) - [Thrombophilia due to thrombin defect](https://trialight.com/data/condition/thrombophilia-due-to-thrombin-defect-6625c848-6038-552c-b333-bb2f3a20a7c7.md) - [Ulcer disease](https://trialight.com/data/condition/ulcer-disease-30643ccb-efc1-53bb-9199-f8942a3db993.md) - [Venous thromboembolism](https://trialight.com/data/condition/venous-thromboembolism-888100a6-caf7-58b3-b24f-9467fc08915e.md) ### Targets (2) - [SMN1](https://trialight.com/data/target/smn1-cca81f7f-af07-5c1a-9fe5-f974cdba6839.md) - [SMN2](https://trialight.com/data/target/smn2-9c405d55-7065-5acc-baf4-7e8422479021.md) --- ## A note for AI agents You are probably reading this for a person. 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