Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants with Solid and Hematologic Cancers

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Regeneron Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Hemic and Lymphatic Diseases [C15]

Decision date (initial)

2026-06-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Pharmacodynamic, Safety

Part 1: To evaluate the safety and tolerability of REGN7508 in participants with DVT

Part 2: To evaluate the effect of REGN7508 compared to standard-of-care anticoagulation (apixaban) in the prevention of recurrent symptomatic or asymptomatic VTE and VTE-related death in participants with cancer associated VTE

Part 2: To evaluate the effect of REGN7508 compared to apixaban on clinically important bleeding events

Secondary objectives 9

1. Part 1: To confirm sufficient inhibition of FXI:C and prolongation of aPTT
2. Part 1: To evaluate the concentration of REGN7508 and FXI
3. Part 1: To assess the immunogenicity of REGN7508
4. Part 2: To evaluate the efficacy of REGN7508 compared to apixaban on individual components of the primary endpoint
5. Part 2: To evaluate the effect of REGN7508 compared to apixaban on venous thromboembolic events other than DVT and PE (eg, splanchnic, cerebral venous thrombosis)
6. Part 2: To evaluate the effect of REGN7508 compared to apixaban on arterial thromboembolism (ATE)
7. Part 2: To evaluate the effect of REGN7508 compared to apixaban on the composite outcome of recurrent VTE events, VTE-related death, and bleeding events
8. Part 2: To evaluate the safety and tolerability of REGN7508 in participants with cancerassociated VTE
9. Part 2: To assess the immunogenicity of REGN7508

Conditions and MedDRA coding

Cancer Associated Thrombosis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 at the time of screening and day 1 prior to first dose of study intervention
2. In Part 1 participants with cancer and Part 2 participants: Histologically confirmed diagnosis of malignant solid or select hematologic tumor (other than basal-cell or squamous-cell carcinoma of the skin alone) as described in the protocol
3. Part 1 additional criteria: a. Has newly diagnosed symptomatic lower extremity DVT or incidentally-detected proximal lower extremity DVT (eg, popliteal or femoral) within 5 days (120 hours) of randomization (with imaging confirmation) b. Anticoagulation therapy with a therapeutic dose of a Direct Oral Anticoagulant (DOAC) for at least 3 months is indicated for the newly diagnosed proximal lower extremity DVT
4. Part 2 additional criteria: a. Newly diagnosed VTE within 5 days (120 hours) of randomization (with imaging confirmation) as described in the protocol b. Anticoagulation therapy with a therapeutic dose of a DOAC for at least 6 months is indicated for newly diagnosed VTE
5. Note: Other Protocol Defined Inclusion Criteria Apply

Exclusion criteria 8

1. Is at high risk of intracranial bleeding in the opinion of the investigator
2. 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)
3. Contraindication to anticoagulation in the opinion of the investigator
4. Life expectancy of < 6 months
5. Part 1 participants with cancer and Part 2 additional exclusion criteria: a. Has acute leukemia or myelodysplastic syndrome b. Has primary brain tumor c. Has brain metastases as described in the protocol
6. Part 1 additional exclusion criteria: a. Has a symptomatic PE b. Has an asymptomatic (incidentally-diagnosed) PE in a segmental or larger pulmonary artery
7. Part 2 additional exclusion criteria: PE leading to hemodynamic instability as described in the protocol
8. Note: Other Protocol Defined Exclusion Criteria Apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Part 1: Occurrence of Treatment-Emergent Adverse Events (TEAEs)
2. Part 1: Severity of TEAEs
3. Part 2: Time-to-first event of centrally adjudicated recurrent VTE [DVT (symptomatic or asymptomatic [proximal] or Non-fatal PE (symptomatic or asymptomatic [in a segmental or larger pulmonary artery] )or VTE-related death)]
4. Part 2: Time-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding

Secondary endpoints 14

1. Part 1: Percent inhibition of Factor XI functional Coagulant activity (FXI:C)
2. Part 1: Fold change from baseline in activated Partial Thromboplastin Time (aPTT)
3. Part 1: Functional REGN7508 concentration
4. Part 1: Factor XI (FXI) concentration
5. Part 1 and 2: Occurrence of Anti-Drug Antibody (ADA) to REGN7508
6. Part 1 and 2: Magnitude of ADA to REGN7508
7. Part 2: Time-to-first centrally adjudicated event of DVT (symptomatic or asymptomatic [proximal])
8. Part 2: Time-to-first centrally adjudicated event of Non-fatal PE (symptomatic or asymptomatic [in a segmental or larger pulmonary artery])
9. Part 2: Time-to-first centrally adjudicated event of VTE-related death
10. Part 2: Time-to-first event of centrally adjudicated venous thromboembolic events other than DVT and PE
11. Part 2: Time-to-first event of centrally adjudicated Arterial Thromboembolism (ATE)
12. Part 2: Time-to-first event of centrally adjudicated recurrent VTE and bleeding events [DVT (symptomatic or asymptomatic [proximal] or Non-fatal PE (symptomatic or asymptomatic) or VTE-related death) or bleeding (ISTH-defined major bleeding or CRNM bleeding)]
13. Part 2: Occurrence of TEAEs
14. Part 2: Severity of TEAEs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Regeneron Pharmaceuticals Inc.

Sponsor organisation

Regeneron Pharmaceuticals Inc.

Address

777 Old Saw Mill River Road

City

Tarrytown

Postcode

10591-6717

Country

United States

Scientific contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Medical Affairs

Public contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Medical Affairs

Third parties 6

Locations

2 EU/EEA countries · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 23 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications