RightFit
RecruitingPhase 3

REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether REGN7508, an experimental drug, can prevent blood clots in adults with solid tumors. It compares the drug with a placebo in people getting cancer treatment, planning to start it within a month of study treatment assignment, or recovering from surgery. It also looks at side effects and how the body responds to the drug.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a solid cancer confirmed by a tissue test that has grown into nearby areas or spread to other parts of the body.
  • Have a Khorana blood clot risk score of 2 or more, or a documented gene change in the tumor linked to a similar clot risk.
  • Have an ECOG activity score of 0 to 2 at screening and before the first dose. This means you can care for yourself and are up and about for at least half the day.

Who can't join

  • Have a bleeding disorder, a tumor site that bleeds, or another condition that raises the risk of bleeding.
  • Have only basal cell or squamous cell skin cancer.
  • Have cancer that started in the brain or spread to the brain, as defined by the study rules.
  • Have a blood clot in a deep vein in the upper part of the leg found by ultrasound during screening.
  • Have another condition that the study doctor thinks could affect the results or make joining unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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

Study sites (4)

FL

NY

TX