Clinical trial • Phase III • Oncology|Haematology|Cardiology

REGN7508 for Cancer-associated thrombosis

Phase III trial of REGN7508 for Cancer-associated thrombosis. Randomised, placebo matching regn7508; dose/schedule not specified-controlled.

Overview

Trial Therapeutic Area
Oncology|Haematology|Cardiology
Trial Disease
Cancer-associated thrombosis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
19-12-2025
First CTIS Authorization Date
27-04-2026

Trial design

Randomised, placebo matching regn7508; dose/schedule not specified-controlled Phase III trial in Bulgaria, Germany, Czechia and others.

Randomised
Yes
Comparator
Placebo matching REGN7508; dose/schedule not specified
Target Sample Size
536

Eligibility

Recruits 536 No vulnerable population selected; participants are adults; informed consent to be obtained from participants; no assent for minors is described in the available documents. Country-specific subject information and informed consent forms are provided..

Vulnerable Population
No vulnerable population selected; participants are adults; informed consent to be obtained from participants; no assent for minors is described in the available documents. Country-specific subject information and informed consent forms are provided.

Inclusion criteria

  • {"criterion_text":"- Has a histologically confirmed diagnosis of malignant solid tumors which are locally advanced or metastatic as described in the protocol .\n- 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 .\n- 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\n- Other Protocol Defined Inclusion Criteria Apply"}

Exclusion criteria

  • {"criterion_text":"- 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).\n- Has a cancer diagnosis consisting solely of basal cell or squamous cell skin carcinoma.\n- Has a primary brain tumor or brain metastases as described in the protocol\n- Has a history of objective evidence of VTE or ATE, including incidental VTE identified by diagnostic imaging requiring anticoagulation.\n- 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.\n- Other Protocol Defined Exclusion Criteria Apply."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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]","definition_or_measurement_approach":"Time-to-first event of centrally adjudicated venous thromboembolism (DVT, non-fatal PE) or arterial thromboembolism (ATE) or thromboembolism-/ATE-related death; events are centrally adjudicated."}
  • {"endpoint_text":"- Time-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH) major bleeding or Clinically Relevant Non-Major (CRNM) bleeding","definition_or_measurement_approach":"Time-to-first event of centrally adjudicated bleeding defined by ISTH criteria (major bleeding) or Clinically Relevant Non-Major (CRNM) bleeding."}

Secondary endpoints

  • {"endpoint_text":"- Time-to-first event of DVT (symptomatic or asymptomatic [proximal]).","definition_or_measurement_approach":"Time-to-first deep vein thrombosis event (symptomatic or asymptomatic proximal DVT)."}
  • {"endpoint_text":"- Time-to-first event of non-fatal PE (symptomatic or asymptomatic).","definition_or_measurement_approach":"Time-to-first non-fatal pulmonary embolism event (symptomatic or asymptomatic)."}
  • {"endpoint_text":"- Time-to-first event of any ATE.","definition_or_measurement_approach":"Time-to-first arterial thromboembolism event."}
  • {"endpoint_text":"- Time-to-first event of thromboembolism- or ATE-related death","definition_or_measurement_approach":"Time-to-first death related to thromboembolism or ATE."}
  • {"endpoint_text":"- Occurrence of Treatment-Emergent Adverse Events (TEAEs)","definition_or_measurement_approach":"Incidence of adverse events emerging during treatment (TEAEs) as collected during study visits."}
  • {"endpoint_text":"- Severity of TEAEs","definition_or_measurement_approach":"Assessment of severity grading of TEAEs (e.g., CTCAE) as recorded in safety reporting."}
  • {"endpoint_text":"- Incidence of Anti-Drug Antibody (ADA) to REGN7508","definition_or_measurement_approach":"Incidence of anti-drug antibody formation to REGN7508 measured by immunogenicity assays."}
  • {"endpoint_text":"- Magnitude of ADA to REGN7508","definition_or_measurement_approach":"Measurement of ADA titre/magnitude to REGN7508 using immunogenicity assays."}

Recruitment

Planned Sample Size
536
Recruitment Window Months
40
Consent Approach
Informed consent obtained from adult participants. Subject information and informed consent forms are provided in country-specific languages (examples present in the documents: Bulgarian, German, Czech, French, Dutch, Polish, Romanian, Spanish). Partner/pregnant-partner information forms are also provided in some countries.

Geography

Total Number Of Sites
72
Total Number Of Participants
324

Bulgaria

Earliest CTIS Part Ii Submission Date
15-04-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
19
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
Multispecialty hospital for active treatment Sveta Sofia EOOD
Department Name
Department vascular surgery
Contact Person Name
Rosen Razboynikov
Site Name
Complex Oncology Center Ruse EOOD
Department Name
Medical Oncology Department
Contact Person Name
Valeriy Yordanov
Contact Person Email
dr_vjordanov@abv.bg

Germany

Earliest CTIS Part Ii Submission Date
07-04-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
22
Number Of Sites
8
Number Of Participants
49

Sites

Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Hematology, oncology, and palliative medicine
Contact Person Name
Dirk ARNOLD
Contact Person Email
d.arnold@asklepios.com
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Hematology, oncology
Contact Person Name
Amin TURKI
Contact Person Email
Amin.Turki@elisabethgruppe.de
Site Name
Klinikum Frankfurt Hoechst GmbH
Department Name
Klinik für Innere Medizin 3 (Hämatologie, Onkologie, Palliativmedizin)
Contact Person Name
Felicitas SCHOLTEN
Contact Person Email
felicitas.scholten@varisano.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Department of Medical Oncology
Contact Person Name
Isabel VIRCHOW
Contact Person Email
lsabel.virchow@uk-essen.de
Site Name
Otto Von Guericke Universitaet Magdeburg
Department Name
Gastroenterologie, Hepatologie und Infektiologie
Contact Person Name
Marino VENERITO
Contact Person Email
m.venerito@med.ovgu.de
Site Name
Sana Kliniken Berlin-Brandenburg GmbH
Department Name
Klinik für Innere Medizin IV - Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Uwe PELZER
Contact Person Email
uwe.pelzer@sana.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Internal Medicine Ill, Hematology and Oncology
Contact Person Name
Christina HART
Site Name
Stiftungsklinikum PROSELIS gGmbH
Department Name
Intestinal cancer, gastroenterology, hepatology and Internistic oncology
Contact Person Name
Thomas HOEHLER
Contact Person Email
Thomas.hoeher@proselis.de

Czechia

Earliest CTIS Part Ii Submission Date
19-01-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
99
Number Of Sites
2
Number Of Participants
16

Sites

Site Name
Multiscan s.r.o.
Contact Person Name
Martin Šmakal
Contact Person Email
msmakal@gmail.com
Site Name
Fakultni Thomayerova nemocnice
Department Name
Onkologická klinika 1. LF UK a FTN
Contact Person Name
Eugen Kubala
Contact Person Email
eugen.kubala@ftn.cz

Belgium

Earliest CTIS Part Ii Submission Date
27-03-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
31
Number Of Sites
8
Number Of Participants
32

Sites

Site Name
Vitaz
Department Name
Medical Oncology
Contact Person Name
Willem Lybaert
Contact Person Email
willem.lybaert@vitaz.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Thoracic & vascular surgery
Contact Person Name
Philip Lerut
Contact Person Email
philip.lerut@azgroeninge.be
Site Name
Hopital De Libramont
Department Name
Oncology
Contact Person Name
Frederic Forget
Contact Person Email
frederic.forget@vivalia.be
Site Name
Algemeen Ziekenhuis Klina
Department Name
Oncology
Contact Person Name
Wim Demey
Contact Person Email
wim.demey@klina.be
Site Name
UZ Leuven
Department Name
Haematology
Contact Person Name
Quentin Van Thillo
Contact Person Email
Quentin.vanthillo@uzleuven.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Oncology
Contact Person Name
Hans Prenen
Contact Person Email
Hans.prenen@uza.be
Site Name
Az Maria Middelares Gent
Department Name
Medical Oncology & haematology
Contact Person Name
Christof Vulsteke
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Medical Haematology
Contact Person Name
Valerie Mathieux

France

Earliest CTIS Part Ii Submission Date
10-04-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
24
Number Of Sites
16
Number Of Participants
54

Sites

Site Name
Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name
Medical Oncology – Avron Site
Contact Person Name
Olivier DUBREUIL
Contact Person Email
odubreuil@hopital-dcss.org
Site Name
Clinique Victor Hugo
Department Name
Oncology – Radiotherapy
Contact Person Name
Thibaut LIZEE
Contact Person Email
essaislizee@ilcgroupe.fr
Site Name
Hopital D'Instruction Des Armees Percy
Department Name
Service de Medecine interne et Rhumatologie
Contact Person Name
Caroline DOUTRELON
Contact Person Email
caro0313@gmail.com
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Oncologie Medicale
Contact Person Name
Sheik EMAMBUX
Contact Person Email
Sheik.emambux@chu-poitiers.fr
Site Name
Assistance Publique Hopitaux De Paris (Clichy)
Department Name
Liver Cancer Unit and therapeutic Innovation
Contact Person Name
Mohamed BOUATTOUR
Contact Person Email
mohamed.bouattour@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris (Colombes)
Department Name
Internal Medicine
Contact Person Name
Isabelle MAHE
Contact Person Email
isabelle.mahe@aphp.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Internal Medicine and Pneumology
Contact Person Name
Francis COUTURAUD
Contact Person Email
francis.couturaud@chu-brest.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Service de Medecine Vasculaire
Contact Person Name
Marie-Antoinette SEVESTRE
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Service de Medecine Vasculaire et Therapeutique
Contact Person Name
Sandrine ACCASSAT
Site Name
Assistance Publique Hopitaux De Paris (Paris - Hopital site)
Department Name
Hepato-Gastroenterology and Digestive Oncology Department
Contact Person Name
Jean-Baptiste BACHET
Contact Person Email
Jean-baptiste.bachet@aphp.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Oncologie Medicale
Contact Person Name
Francois GHIRINGHELLI
Contact Person Email
fghiringhelli@cgfl.fr
Site Name
Institut De Cancerologie De Lorraine
Department Name
Medical Oncology
Contact Person Name
Aurelien LAMBERT
Contact Person Email
a.lambert@nancy.unicancer.fr
Site Name
CHU Besancon
Department Name
Oncologie Medicale
Contact Person Name
Christophe BORG
Contact Person Email
xtoph.borg@gmail.com
Site Name
Institut Bergonie
Department Name
Medical Oncology
Contact Person Name
Florent PEYRAUD
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncologie medicale
Contact Person Name
Bettina BOUTRUCHE

Romania

Earliest CTIS Part Ii Submission Date
27-03-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
38
Number Of Sites
11
Number Of Participants
49

Sites

Site Name
Oncolab S.R.L.
Department Name
Medical Oncology
Contact Person Name
Cristian-Virgil Lungulescu
Contact Person Email
cristilungulescu@yahoo.com
Site Name
Ovidius Clinical Hospital S.R.L.
Department Name
Medical Oncology Clinique
Contact Person Name
Laura Mazilu
Contact Person Email
lauragrigorov@gmail.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Medical Oncology
Contact Person Name
Tudor-Eliade Ciuleanu
Site Name
Medicover S.R.L.
Department Name
Medical Oncology
Contact Person Name
Radu Emanuel Baerceanu-Ion
Contact Person Email
radu.berceanu@ionco.ro
Site Name
Oncocenter Oncologie Clinica S.R.L.
Department Name
Oncology Clinique
Contact Person Name
Roxana Ioana Scheusan
Contact Person Email
roxana.scheusan@oncocenter.ro
Site Name
Gral Medical S.R.L.
Department Name
Medical Oncology
Contact Person Name
Adela Luiza Chirila
Contact Person Email
dr.adela_chirila@yahoo.com
Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Oncology
Contact Person Name
Constantin Volovat
Contact Person Email
cvolovat@gmail.com
Site Name
Sigmedical Services S.R.L.
Department Name
Medical Oncology
Contact Person Name
Doina Elena Ganea Motan
Contact Person Email
motan_doina@yahoo.com
Site Name
Oncomed S.R.L.
Department Name
Medical Oncology
Contact Person Name
Mihaela-Maria Pasca-Fenesan
Contact Person Email
fenesan.mihaela@gmail.com
Site Name
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
Department Name
Medical Oncology
Contact Person Name
Adrian-Radu Vidra
Contact Person Email
raduvidra@gmail.com
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Medical Oncology II Section
Contact Person Name
Laurentia Nicoleta Gales

Poland

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
31
Number Of Sites
10
Number Of Participants
43

Sites

Site Name
Specjalistyczne Gabinety Sp. z o.o.
Department Name
-
Contact Person Name
Joanna Streb
Site Name
Aidport Sp. z o.o.
Department Name
AIDPORT
Contact Person Name
Michał Kwiatek
Contact Person Email
rejestracja@aidport.pl
Site Name
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej, Chemioterapii
Contact Person Name
Wojciech Rogowski
Contact Person Email
onkologia@szpital.slupsk.pl
Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Klinika Onkologii
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Poradnia Onkologiczna oraz Oddział Kliniczny Onkologii
Contact Person Name
Piotr Wysocki
Contact Person Email
klinikaonkologii@su.krakow.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Dagmara Buczek
Contact Person Email
onkol@gumed.edu.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotowrów Płuca i Klatki Piersiowej
Contact Person Name
Dariusz Kowalski
Contact Person Email
paulina.kukwa@nio.gov.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
Futuremeds Sp. z o.o.
Department Name
Futuremeds Olsztyn
Contact Person Name
Maciej Żechowicz
Site Name
Other Polish site (listed)

Spain

Earliest CTIS Part Ii Submission Date
17-04-2026
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
19
Number Of Sites
15
Number Of Participants
70

Sites

Site Name
Hospital Quironsalud Barcelona
Department Name
IOB Institute of Oncology
Contact Person Name
David Jimenez Ruiz de la Torre
Contact Person Email
david.jimenez@iob-onco.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Aranzazu Manzano Fernandez
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Oncology
Contact Person Name
Miguel Marin Vera
Contact Person Email
miguel.marin2@carm.es
Site Name
Hospital Universitario Miguel Servet
Department Name
Oncology
Contact Person Name
Paula Gomila Pons
Contact Person Email
pgomila@salud.aragon.es
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Antonio Cubillo Gracian
Contact Person Email
acubillo@hmhospitales.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Manuel Jesus Valladares Ayerbes
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Andres Jesus Munoz Martin
Contact Person Email
andresmunmar@hotmail.com
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Contact Person Name
Jaime Feliu Batlle
Contact Person Email
jaime.feliu@salud.madrid.org
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Oncology
Contact Person Name
Silvia Sequero Lopez
Contact Person Email
silsq90@gmail.com
Site Name
Hospital Universitario Hm Monteprincipe
Department Name
Oncology
Contact Person Name
Antonio Cubillo Gracian
Contact Person Email
acubillo@hmhospitales.com
Site Name
Hospital De Jerez De La Frontera
Department Name
Oncology
Contact Person Name
Maria Jose Contreras Gonzalez
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Oncology
Contact Person Name
Bartomeu Massuti Sureda
Contact Person Email
bmassutis@seom.org
Site Name
Hospital Universitario Hm Puerta Del Sur
Department Name
Oncology
Contact Person Name
Antonio Cubillo Gracian
Contact Person Email
acubillo@hmhospitales.com
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Oncology
Contact Person Name
Maria Irene Torres Ramon
Contact Person Email
mitorres@salud.aragon.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Eva Ruiz Hispan
Contact Person Email
eva.ruizh@quironsalud.es

Sponsor

Primary sponsor

Full Name
Regeneron Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
CRO
Name
Parexel International (IRL) Limited
Responsibilities
CRO

Third parties

  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Central Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Colorado Prevention Center","duties_or_roles":"Adjudication","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
REGN7508
Active Substance
REGN7508
Modality
Monoclonal antibody
Routes Of Administration
INJECTION
Route
INJECTION
Authorisation Status
1
Investigational Product Name
Placebo matching REGN7508
Modality
Other

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