REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis.

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

Decision date (initial)

2026-04-27

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: Efficacy, Safety, Pharmacokinetic, Pharmacodynamic, Others

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.

Secondary objectives 3

1. To evaluate the efficacy of REGN7508 compared to placebo on individual components of the primary endpoint
2. To evaluate the safety and tolerability of REGN7508 in participants with solid tumors undergoing cancer treatment
3. To assess immunogenicity of REGN7508

Conditions and MedDRA coding

Cancer-Associated Thrombosis (CAT).

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 4

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
4. Other Protocol Defined Inclusion Criteria Apply

Exclusion criteria 6

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.
6. Other Protocol Defined Exclusion Criteria Apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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]
2. Time-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH) major bleeding or Clinically Relevant Non-Major (CRNM) bleeding

Secondary endpoints 8

1. Time-to-first event of DVT (symptomatic or asymptomatic [proximal]).
2. Time-to-first event of non-fatal PE (symptomatic or asymptomatic).
3. Time-to-first event of any ATE.
4. Time-to-first event of thromboembolism- or ATE-related death
5. Occurrence of Treatment-Emergent Adverse Events (TEAEs)
6. Severity of TEAEs
7. Incidence of Anti-Drug Antibody (ADA) to REGN7508
8. Magnitude of ADA to REGN7508

Investigational products

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

Test 1

Placebo 1

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

8 EU/EEA countries · 72 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 61 files

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

Application history

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