Recruiting
Phase 3

REGN7508

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07410117

Conditions

Cancer-Associated Thrombosis (CAT)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REGN7508

Placebo

Study Details

Brief 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)

Conditions

Cancer-Associated Thrombosis (CAT)

Study ID

NCT07410117

Start date

Mar 9, 2026

Status verified date

May, 2026

Completion date

May 6, 2030

Anticipated

Primary completion date

Jan 23, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: REGN7508

placebo comparator: Placebo

Interventions

REGN7508

Administered per the protocol

Placebo

Administered per the protocol

Primary outcome measure

  • Time-to-first event of centrally adjudicated VTE (DVT, PE) or ATE, or thromboembolism- or ATE-related death [ Time Frame: 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 [ Time Frame: Through 6 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Bioresearch Partner- Hialeah Hospital

Recruiting

Hialeah, Florida, United States, 33013

Helios Clinical Research

Recruiting

North Miami Beach, Florida, United States, 33169

El Paso Medical Research Institute (Medresearch Inc)

Recruiting

El Paso, Texas, United States, 79902

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 20, 2026

Last verified

May, 2026

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)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-20.