Cancer-Associated Thrombosis (CAT)
Conditions
Interventions
-Drug: REGN7508
Administered per the protocol
-Drug: Placebo
Administered per the protocol
Sponsors
Inomata Hyoe
Eligibility
Sex/Gender
All
Inclusion criteria
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 Note: Other Protocol Defined Inclusion Criteria Apply
Exclusion criteria
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 a history of objective evidence of VTE or ATE, including incidental VTE identified by diagnostic imaging requiring anticoagulation 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 Exclusion Criteria Apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Time-to-first event of centrally adjudicated VTE [Deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE) or Arterial thromboembolism (ATE), or thromboembolism- or ATE-related death] -Time-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH) major bleeding or Clinically Relevant Non-Major (CRNM) bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| -Time-to-first event of DVT (symptomatic or asymptomatic [proximal]) -Time-to-first event of non-fatal PE (symptomatic or asymptomatic) -Time-to-first event of any ATE -Time-to-first event of thromboembolism- or ATE-related death -Occurrence of Treatment-Emergent Adverse Events (TEAEs) -Severity of TEAEs -Incidence of Anti-Drug Antibody (ADA) to REGN7508 -Magnitude of ADA to REGN7508 | — |
Countries
Australia, Belgium, Brazil, Bulgaria, Canada, Czech Republic, France, Georgia, Germany, Japan, Poland, Roumania, South Korea, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactRegeneron Japan Contact for Clinical Trial
Regeneron Japan KK
Outcome results
None listed