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)
Regeneron Pharmaceuticals
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)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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, Hemop…
Interventions
- DrugREGN7508
Administered per the protocol
- DrugPlacebo
Administered per the protocol
Locations (12)
- Bioresearch Partner- Hialeah HospitalHialeah, Florida
- Helios Clinical ResearchNorth Miami Beach, Florida
- El Paso Medical Research Institute (Medresearch Inc)El Paso, Texas
- LTD High Technology Hospital MedcenterBatumi, Adjara
- Krystyna Kiel Oncology CenterKutaisi, Imereti
- American Hospital TbilisiTbilisi