Recruiting
Phase 3

REGN7508

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07493304

Conditions

Venous Thromboembolism (VTE)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REGN7508

Apixaban

Study Details

Brief summary:

This study is researching an experimental drug called REGN7508 (called "study drug") and will consist of 2 parts: Part 1 and Part 2. The study is focused on participants with or without cancer who develop blood clots in certain veins (called Deep Vein Thrombosis \[DVT\]) that block blood flow (Part 1) or focused on participants with cancer who develop blood clots in certain veins (DVT) or the lungs (also called Pulmonary Embolism \[PE\]) (Part 2).

The aim of the study is to see how safe and effective the study drug is at treating and preventing further blood clots in participants with or without cancer (Part 1) or in participants with cancer (Part 2) compared with another treatment (apixaban).

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 drug less effective or could lead to side effects)

Conditions

Venous Thromboembolism (VTE)

Study ID

NCT07493304

Start date

Aug 31, 2026

Status verified date

Aug, 2026

Completion date

Jul 8, 2031

Anticipated

Primary completion date

Jul 8, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 at the time of screening and day 1 prior to first dose of study intervention
2. In Part 1 participants with cancer and Part 2 participants: Histologically confirmed diagnosis of malignant solid or select hematologic tumor (other than basal-cell or squamous-cell carcinoma of the skin alone) as described in the protocol
3. Part 1 additional criteria:

1. Has newly diagnosed symptomatic lower extremity DVT or incidentally-detected proximal lower extremity DVT (eg, popliteal or femoral) within 5 days (120 hours) of randomization (with imaging confirmation)
2. Anticoagulation therapy with a therapeutic dose of a Direct Oral Anticoagulant (DOAC) for at least 3 months is indicated for the newly diagnosed proximal lower extremity DVT
4. Part 2 additional criteria:

1. Newly diagnosed VTE within 5 days (120 hours) of randomization (with imaging confirmation) as described in the protocol
2. Anticoagulation therapy with a therapeutic dose of a DOAC for at least 6 months is indicated for newly diagnosed VTE

Key Exclusion Criteria:

1. Is at high risk of intracranial bleeding in the opinion of the investigator
2. 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)
3. Contraindication to anticoagulation in the opinion of the investigator
4. Life expectancy of < 6 months
5. Part 1 participants with cancer and Part 2 additional exclusion criteria:

1. Has acute leukemia or myelodysplastic syndrome
2. Has primary brain tumor
3. Has brain metastases as described in the protocol
6. Part 1 additional exclusion criteria:

1. Has a symptomatic PE
2. Has an asymptomatic (incidentally-diagnosed) PE in a segmental or larger pulmonary artery
7. Part 2 additional exclusion criteria: PE leading to hemodynamic instability as described in the protocol

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Study Design

Enrollment

1600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: REGN7508

active comparator: Apixaban

Interventions

REGN7508

Administered per the protocol

Apixaban

Administered per the protocol

Primary outcome measure

  • Occurrence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Approximately 6 months ]
  • Severity of TEAEs [ Time Frame: Approximately 6 months ]
  • Time-to-first event of centrally adjudicated recurrent VTE [DVT (symptomatic or asymptomatic [proximal] or Non-fatal PE (symptomatic or asymptomatic [in a segmental or larger pulmonary artery] )or VTE-related death)] [ Time Frame: Up to approximately 3.5 years ]
  • Time-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding [ Time Frame: Up to approximately 3.5 years ]

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

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

El Paso Medical Research Institute (Medresearch Inc)

Recruiting

El Paso, Texas, United States, 79902

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Cancer-Associated Thrombosis (CAT)
  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism (PE)
  • Cancer

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 2026-08-19.