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)

未提供0 个研究点目标入组 86 人开始时间: 待定

试验速览

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•Has a histologically confirmed diagnosis of malignant solid tumors which are locally advanced or metastatic as described in the protocol
•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
•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

•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)
•Has a cancer diagnosis consisting solely of basal cell or squamous cell skin carcinoma
•Has a primary brain tumor or brain metastases as described in the protocol
•Has a history of objective evidence of VTE or ATE, including incidental VTE identified by diagnostic imaging requiring anticoagulation
•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

发起方

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