2024-519298-21-00
Recruiting
Phase 3
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 Inc.0 sites140 target enrollmentStarted: June 1, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Enrollment
- 140
Overview
Brief Summary
1.To evaluate the effect of REGN7508 compared to placebo in the prevention of CAT in participants with solid tumors undergoing cancer treatment. 2. To evaluate the effect of REGN7508 compared to placebo on clinically important bleeding events.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Other Protocol Defined Inclusion Criteria Apply
Exclusion Criteria
- •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.
- •Other Protocol Defined Exclusion Criteria Apply.
Arms & Interventions
Group with
Placebo
Investigators
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.
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