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)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519298-21-00

Enrollment

Registered

2026-04-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer-Associated Thrombosis (CAT).

Brief summary

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

Detailed description

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

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

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	—

Outcome results