1120 Participants NeededMy employer runs this trial

REGN7508 for Cancer-Related Blood Clots

(ROXI-CAT-I Trial)

Recruiting at 19 trial locations
CT
Overseen ByClinical Trials Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Regeneron Pharmaceuticals
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, REGN7508, to determine its ability to prevent blood clots in people with solid tumors undergoing cancer treatment. It compares the drug to a placebo (a harmless pill with no active medicine) to assess its effectiveness. The study also examines side effects, the drug's movement in the body, and whether the body produces antibodies against it. People diagnosed with advanced cancer and at higher risk for blood clots might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in cancer treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that REGN7508 is likely to be safe for humans?

Research has shown that REGN7508 is generally safe for patients. In earlier studies, no treatment-related deaths occurred among those taking REGN7508. This suggests the treatment is reasonably safe for preventing blood clots, even in people with cancer or those undergoing surgery. While side effects can occur with any medication, these findings provide reassurance about the safety of REGN7508.12345

Why do researchers think this study treatment might be promising for cancer-related blood clots?

Unlike the standard treatments for cancer-related blood clots, which typically involve anticoagulants like warfarin or direct oral anticoagulants (DOACs), REGN7508 offers a novel approach. This experimental drug is designed to specifically target and address the blood clotting process associated with cancer, potentially offering a more focused treatment. Researchers are excited because REGN7508 may provide better outcomes with fewer side effects, addressing a significant need for safer, more effective options in managing blood clots linked to cancer.

What evidence suggests that REGN7508 might be an effective treatment for cancer-related blood clots?

Research has shown that REGN7508 effectively prevents blood clots in people with cancer. In one study, only 7% of participants taking REGN7508 developed blood clots, compared to 21% for those on enoxaparin and 12% for those on apixaban. This indicates that REGN7508 is more effective at preventing blood clots than these other treatments. In this trial, participants will receive either REGN7508 or a placebo to further evaluate its effectiveness and safety. The drug has successfully prevented a specific type of blood clot called venous thromboembolism. Researchers aim to determine whether it can reduce the risk of blood clots without increasing side effects. Early results suggest it could be a promising option for people with cancer who are at risk for blood clots.12467

Who Is on the Research Team?

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with advanced or spreading solid tumors who are at higher risk of blood clots, either due to their cancer type/genetics or a high Khorana score. Participants must be starting or already on cancer treatment, or recently had surgery, and need to be well enough for daily activities.

Inclusion Criteria

I have been diagnosed with an advanced or metastatic solid tumor.
I meet a key requirement for the study.
I have a high risk of blood clots based on my score or tumor genetics.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive REGN7508 or placebo to prevent Cancer-Associated Thrombosis while undergoing anticancer treatment

12 weeks
Bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • REGN7508

Trial Overview

The study compares an experimental drug called REGN7508 to a placebo (inactive substance) to see if it can prevent dangerous blood clots in people with cancer. Participants are randomly assigned to receive either the study drug or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: REGN7508Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41218619/

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