Cancer-Associated Thrombosis (CAT)Phase 3ROXI-CAT-INCT07410117
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
A Phase 3 study testing REGN7508 in people with Cancer-Associated Thrombosis (CAT), run by Regeneron Pharmaceuticals at 23 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-Associated Thrombosis (CAT)
- What is being tested?
- REGN7508
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,120 participants
- Where
- 23 sitesin 3 countries
- Study dates
- 9 Mar 2026to 6 May 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 3 countries
Japan10 sites, 10 recruiting
- Recruiting
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558
- Recruiting
National Hospital Organization Osaka National Hospital (ONH)
Chuo, Osaka, 540-0006
- Recruiting
Saitama Cancer Center
Ina-machi, Saitama, 362-0806
- Recruiting
Tokai University Hospital
Isehara-Shi, Kanagawa, 259-1193
- Recruiting
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793
- Recruiting
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566
- Recruiting
Niigata University Medical & Dental Hospital
Niigata, 951-8520
- Recruiting
Tokyo Medical University Hospital
Shinjuku, Tokyo, 160-0023
- Recruiting
Ehime University Hospital
Tōon, Ehime, 791-0295
- Recruiting
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505
Georgia9 sites, 9 recruiting
- Recruiting
LTD High Technology Hospital Medcenter
Batumi, Adjara, 6000
- Recruiting
Krystyna Kiel Oncology Center
Kutaisi, Imereti, 4600
- Recruiting
American Hospital Tbilisi
Tbilisi, 0102
- Recruiting
Llc Todua Clinic
Tbilisi, 0112
- Recruiting
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, 0144
- Recruiting
Institute of Clinical Oncology
Tbilisi, 0159
- Recruiting
JSC Evex Hospitals - Caraps Medline
Tbilisi, 0179
- Recruiting
LTD Cancer Research Centre
Tbilisi, 0179
- Recruiting
Caucasus Medical Centre
Tbilisi, 0186
United States4 sites, 4 recruiting
- Recruiting
El Paso Medical Research Institute (Medresearch Inc)
El Paso, Texas, 79902
- Recruiting
Bioresearch Partner- Hialeah Hospital
Hialeah, Florida, 33013
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
- Recruiting
Helios Clinical Research
North Miami Beach, Florida, 33169
About this study
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)
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.
Read more
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)
- Conditions
- Cancer-Associated Thrombosis (CAT)
- Being tested
- REGN7508, Placebo
- Keywords
- Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Arterial Thromboembolism (ATE), Solid tumors (cancers), Clinically Relevant Non-Major (CRNM) bleeding, International Society of Thrombosis and Hemostasis (ISTH)
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Neoplasms, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN7508Drug
Also called cenvacibart
Administered per the protocol
PlaceboDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| REGN7508 | Experimental | Not described Receives: Drug: REGN7508 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-first event of centrally adjudicated VTE (DVT, PE) or ATE, or thromboembolism- or ATE-related death
Measured: 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
Measured: Through 6 months
Secondary outcomes (16)
Time-to-first event of the centrally adjudicated symptomatic or incidental VTE (DVT, PE) or ATE and thromboembolism- or ATE-related death
Measured: Through 6 months
Time-to-first event of symptomatic VTE
Measured: Through 6 months
Time-to-first event of symptomatic DVT
Measured: Through 6 months
Time-to-first event of symptomatic non-fatal PE
Measured: Through 6 months
Time-to-first event of thromboembolism-related death
Measured: Through 6 months
Time-to-first event of incidental VTE
Measured: Through 6 months
Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT
Measured: Through 6 months
Time-to-first event of incidental non-fatal PE (in a segmental or larger pulmonary artery)
Measured: Through 6 months
Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by lower extremities ultrasound)
Measured: Through 6 months
Time-to-first event of ATE
Measured: Through 6 months
Time-to-first event of ATE-related death
Measured: Through 6 months
Time-to-first event of centrally adjudicated VTE (DVT, PE), or thromboembolism-related death
Measured: Through 6 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to day 245
Severity of TEAEs
Measured: Up to day 245
Occurrence of Anti-Drug Antibody (ADA) to REGN7508
Measured: Up to day 245
Magnitude of ADA to REGN7508
Measured: Up to day 245
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start9 Mar 2026
- Primary completion23 Jan 2030 (estimated)
- Study completion6 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-Associated Thrombosis (CAT)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410117
- Sponsor's protocol ID
- R7508-CAT-2392
- Other IDs
- 2024-519298-21-00
- Acronym
- ROXI-CAT-I
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.