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)

New Drug Trial Aims to Prevent Blood Clots in Cancer Patients

NCT: NCT07410117 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Regeneron Pharmaceuticals · Started: 2026-03-09 · Est. Completion: 2030-05-06

Plain English Summary

REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis is a Phase 3 clinical trial sponsored by Regeneron Pharmaceuticals studying Cancer-Associated Thrombosis (CAT). This trial tests a new drug, REGN7508, to see if it can prevent dangerous blood clots in people with solid tumors who are undergoing cancer treatment. It is for adults with solid tumors who are at high risk for blood clots and are receiving or planning to start cancer treatment or have recently had surgery. Participants will receive either the study drug or a placebo (a dummy treatment) through injection, and will be closely monitored for blood clots and side effects. Currently, standard treatments for preventing blood clots in cancer patients often involve blood thinners that can increase bleeding risk; this trial explores a new approach. The trial aims to enroll 860 participants.

Official 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)

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have a confirmed diagnosis of advanced or metastatic solid tumors and are at high risk for blood clots. You cannot join if you have a history of bleeding disorders, active bleeding, brain tumors or metastases, or a previous blood clot requiring treatment. Participants must be adults (age not specified) and have a good general health status (ECOG performance status 0-2). This trial is studying Cancer-Associated Thrombosis (CAT), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how long it takes for a participant to experience a blood clot (in veins or arteries) or a serious bleeding event, indicating the drug's effectiveness in preventing clots The specific primary outcome measures are: Time-to-first event of centrally adjudicated VTE [Deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE) or Arterial thromboembolism (ATE), or thromboembolism- or ATE-related death] (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 (Through 6 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a significant unmet need by investigating a novel therapy to prevent cancer-associated blood clots, a common and serious complication that can impact treatment and survival. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Cancer-Associated Thrombosis (CAT), where improved treatment options are needed.

Investor Insight

This trial targets the large and growing market for cancer supportive care, with a focus on preventing a major cause of morbidity and mortality in cancer patients, potentially offering a new standard Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 860 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about your specific risk of blood clots and if this trial is a good fit for you. Understand that you will receive either the study drug or a placebo, and participation involves regular clinic visits, blood draws, and monitoring for side effects. Be prepared for potential injections and follow-up appointments to assess your health and any treatment effects. This trial is currently recruiting participants. The trial is being conducted at 12 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

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 at the time of screening or harbors a somatic documented tumor genetic variant known to be associated with an 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 a history of objective evidence of VTE or ATE, including incidental VTE identified by diagnostic imaging requiring anticoagulation
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

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07410117?

NCT07410117 is a Phase 3 INTERVENTIONAL study titled "REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis." It is currently recruiting and is sponsored by Regeneron Pharmaceuticals. The trial targets enrollment of 860 participants.

What conditions does NCT07410117 study?

This trial investigates treatments for Cancer-Associated Thrombosis (CAT). The primary condition under study is Cancer-Associated Thrombosis (CAT).

What treatments are being tested in NCT07410117?

The interventions being studied include: REGN7508 (DRUG), Placebo (DRUG). Administered per the protocol

What does Phase 3 mean for NCT07410117?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT07410117?

This trial is currently "Recruiting." It started on 2026-03-09. The estimated completion date is 2030-05-06.

Who is sponsoring NCT07410117?

NCT07410117 is sponsored by Regeneron Pharmaceuticals. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07410117?

The trial aims to enroll 860 participants. The trial is currently recruiting and accepting new participants.

How is NCT07410117 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT07410117?

The primary outcome measures are: Time-to-first event of centrally adjudicated VTE [Deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE) or Arterial thromboembolism (ATE), or thromboembolism- or ATE-related death] (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 (Through 6 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07410117 being conducted?

This trial is being conducted at 12 sites, including Hialeah, Florida; North Miami Beach, Florida; El Paso, Texas; Batumi, Adjara and 8 more sites (United States, Georgia).

Where can I find official information about NCT07410117?

The official record for NCT07410117 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07410117. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07410117 testing in simple terms?

This trial tests a new drug, REGN7508, to see if it can prevent dangerous blood clots in people with solid tumors who are undergoing cancer treatment. It is for adults with solid tumors who are at high risk for blood clots and are receiving or planning to start cancer treatment or have recently had surgery.

Why is this trial significant?

This trial addresses a significant unmet need by investigating a novel therapy to prevent cancer-associated blood clots, a common and serious complication that can impact treatment and survival. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT07410117?

The main risk is bleeding, as the drug works by affecting blood clotting. Other potential side effects may include reactions at the injection site or other unexpected issues that will be monitored by the study team. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07410117?

Ask your doctor about your specific risk of blood clots and if this trial is a good fit for you. Understand that you will receive either the study drug or a placebo, and participation involves regular clinic visits, blood draws, and monitoring for side effects. Be prepared for potential injections and follow-up appointments to assess your health and any treatment effects. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07410117 signal from an investment perspective?

This trial targets the large and growing market for cancer supportive care, with a focus on preventing a major cause of morbidity and mortality in cancer patients, potentially offering a new standard This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participants will receive either the study drug or a placebo (a dummy treatment) through injection, and will be closely monitored for blood clots and side effects. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.