臨床研究等提出・公開システム

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)

REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis (ROXI-CAT-I)

Inomata Hyoe

Regeneron Japan KK

Toranomon Hills Station Tower 18F, 2-6-1 Toranomon, Minato-ku, Tokyo

Clinicaltrial-sciences@regeneron.com

Regeneron Japan Contact for Clinical Trial

Regeneron Japan KK

Toranomon Hills Station Tower 18F, 2-6-1 Toranomon, Minato-ku, Tokyo

+81-3-6630-7478

Clinicaltrial-sciences@regeneron.com

Pending

July. 31, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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

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

Both

Cancer-Associated Thrombosis (CAT)

- Drug: REGN7508
Administered per the protocol
- Drug: Placebo
Administered per the protocol

- 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

- 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

+81-276-38-0771

Mar. 26, 2026

Yes

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Brazil/Germany/Poland/United Kingdom/France/Belgium/Spain/Roumania/Georgia/Turkey/Czech Republic/Bulgaria/Australia/South Korea/Taiwan/United States/Canada