Clinical trial • Phase III • Oncology

SACITUZUMAB TIRUMOTECAN for Triple-negative breast cancer (locally recurrent unresectable or metastatic)

Phase III trial of SACITUZUMAB TIRUMOTECAN for Triple-negative breast cancer (locally recurrent unresectable or metastatic).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Triple-negative breast cancer (locally recurrent unresectable or metastatic)
Trial Stage
Phase III
Drug Modality
ADC|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
31-01-2025
First CTIS Authorization Date
04-07-2025

Trial design

Randomised, open-label, treatment of physician's choice (tpc) options: paclitaxel; nab-paclitaxel; gemcitabine + carboplatin. dose and schedule not specified in the ctis record.-controlled Phase III trial in Romania, Spain, Denmark and others.

Randomised
Yes
Open Label
Yes
Comparator
Treatment of Physician's Choice (TPC) options: paclitaxel; nab-paclitaxel; gemcitabine + carboplatin. Dose and schedule not specified in the CTIS record.
Biomarker Stratified
True, PD-L1 (combined positive score CPS <10)
Target Sample Size
680

Eligibility

Recruits 680 No vulnerable populations selected (isVulnerablePopulationSelected=false). Informed consent required from adult participants; country-specific informed consent forms available. No assent/parental consent arrangements are described in the CTIS record..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected=false). Informed consent required from adult participants; country-specific informed consent forms available. No assent/parental consent arrangements are described in the CTIS record.

Inclusion criteria

  • {"criterion_text":"- Has locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) that cannot be treated with curative intent"}
  • {"criterion_text":"- Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer"}
  • {"criterion_text":"- Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months (180 days) before the first disease recurrence"}
  • {"criterion_text":"- Is a candidate for treatment with pembrolizumab and one of the treatment of physician's choice (TPC) options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin"}
  • {"criterion_text":"- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible"}
  • {"criterion_text":"- Human Immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)"}
  • {"criterion_text":"- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load"}
  • {"criterion_text":"- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable"}

Exclusion criteria

  • {"criterion_text":"- Has breast cancer amenable to treatment with curative intent"}
  • {"criterion_text":"- Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease"}
  • {"criterion_text":"- Has known additional malignancy that is progressing or has required active treatment within the past 5 years"}
  • {"criterion_text":"- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable"}
  • {"criterion_text":"- Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed"}
  • {"criterion_text":"- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease"}
  • {"criterion_text":"- Concurrent active Hepatitis B (defined as hepatitis B surface antigen (HBsAg) positive and/or detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection"}
  • {"criterion_text":"- History of stem cell/solid organ transplant"}
  • {"criterion_text":"- Has not adequately recovered from major surgery or has ongoing surgical complications"}
  • {"criterion_text":"- Has triple-negative breast cancer (TNBC) with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10"}
  • {"criterion_text":"- Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer"}
  • {"criterion_text":"- Has Grade ≥2 peripheral neuropathy"}
  • {"criterion_text":"- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing"}
  • {"criterion_text":"- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease"}
  • {"criterion_text":"- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease"}
  • {"criterion_text":"- Has skin only metastatic disease"}
  • {"criterion_text":"- Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC)","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by Blind Independent Central Review (BICR) (stated in trial objectives)"}
  • {"endpoint_text":"- Overall Survival (OS) (sac-TMT versus TPC)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Overall Survival (OS) (sac-TMT plus pembrolizumab versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus sac-TMT)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Progression-Free Survival (PFS) (sac-TMT plus pembrolizumab versus sac-TMT)","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by Blind Independent Central Review (BICR) (stated in secondary objectives)"}
  • {"endpoint_text":"- Objective Response Rate (ORR) (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)","definition_or_measurement_approach":"ORR per RECIST 1.1 as assessed by Blind Independent Central Review (BICR) (stated in secondary objectives)"}
  • {"endpoint_text":"- Duration of Response (DOR)","definition_or_measurement_approach":"DOR per RECIST 1.1 as assessed by Blind Independent Central Review (BICR) (stated in secondary objectives)"}
  • {"endpoint_text":"- Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)","definition_or_measurement_approach":"Measured using the EORTC QLQ-C30 questionnaire"}
  • {"endpoint_text":"- Change from baseline in physical functioning score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)","definition_or_measurement_approach":"Measured using the EORTC QLQ-C30 questionnaire (physical functioning domain)"}
  • {"endpoint_text":"- Change from baseline in emotional functioning score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)","definition_or_measurement_approach":"Measured using the EORTC QLQ-C30 questionnaire (emotional functioning domain)"}
  • {"endpoint_text":"- Change from baseline in fatigue score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)","definition_or_measurement_approach":"Measured using the EORTC QLQ-C30 questionnaire (fatigue domain)"}
  • {"endpoint_text":"- Change from baseline in diarrhea score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)","definition_or_measurement_approach":"Measured using the EORTC QLQ-C30 questionnaire (diarrhea item)"}
  • {"endpoint_text":"- Number of participants who experience one or more adverse events (AEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of participants who discontinue study treatment due to an AE","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
680
Recruitment Window Months
58
Consent Approach
Informed consent obtained from adult participants. Country-specific subject information and informed consent forms are provided (documents available in multiple languages such as Romanian, English, Spanish, Dutch, French, German, Greek, Hungarian, Polish, Italian, Czech, Finnish per CTIS document list). Optional consent/ICF modules (eg, optional pregnant partner, optional Greenphire/ePRO) are available as country-specific addenda.

Geography

Total Number Of Sites
81
Total Number Of Participants
320

Romania

Earliest CTIS Part Ii Submission Date
07-05-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
348
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
Oncomed S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Cristina Oprean
Contact Person Email
office@oncohelp.ro
Site Name
Mnt Healthcare Europe S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Dan-Corneliu Jinga
Contact Person Email
dan.jinga@neolife.ro
Site Name
Spitalul Municipal Ploiesti
Department Name
Oncologie Medicala
Contact Person Name
Pompilia Motatu
Contact Person Email
spitalschuller@yahoo.com
Site Name
Spitalul Clinic Filantropia
Department Name
Oncologie Medicala
Contact Person Name
Mircea Median
Contact Person Email
office@spitalulfilantropia.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncologie Medicala
Contact Person Name
Nicoleta Antone
Contact Person Email
office@iocn.ro
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Michael Schenker
Contact Person Email
office@centruldeoncologie.ro
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Andrei Ungureanu
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Michael Schenker
Contact Person Email
office@centruldeoncologie.ro

Spain

Earliest CTIS Part Ii Submission Date
13-05-2025
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
338
Number Of Sites
7
Number Of Participants
38

Sites

Site Name
Hospital Beata Maria Ana
Department Name
Medical Oncology
Contact Person Name
Javier Cortes Castán
Contact Person Email
javier.cortes@maj3.health
Site Name
Hospital Del Mar
Department Name
Oncology
Contact Person Name
Maria Martinez Garcia
Contact Person Email
mariamartinezgarcia@psmar.cat
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Contact Person Name
Sonia Pernas Simón
Site Name
Hospital Clinico San Carlos
Department Name
Medical Oncology
Contact Person Name
Jose Angel Garcia Saenz
Contact Person Email
jgsaenz@salud.madrid.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical Oncology
Contact Person Name
Maria Fernandez Abad
Contact Person Email
mariafernandezabad@hotmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Medical Oncology
Contact Person Name
Jose Salvador Bofill
Contact Person Email
jsalvad2002@yahoo.es
Site Name
Hospital General Universitario De Valencia
Department Name
Oncology
Contact Person Name
Vega Iranzo González-Cruz
Contact Person Email
iranzo_veg@gva.es

Denmark

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
208
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Region Midtjylland
Department Name
Department of Oncology
Contact Person Name
Christian Tang Axelsen
Contact Person Email
CHRAXE@rm.dk
Site Name
Rigshospitalet
Department Name
Department of Oncology
Contact Person Name
Christina Bjerre
Site Name
Odense University Hospital
Department Name
Department of Oncology
Contact Person Name
Jeanette Dupont Rønlev
Contact Person Email
ouh.ode.r.ctis@rsyd.dk
Site Name
Region Hovedstaden
Department Name
Department of Oncology
Contact Person Name
Malgorzata Tuxen
Contact Person Email
malgorzata.tuxen@regionh.dk

Germany

Earliest CTIS Part Ii Submission Date
14-08-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
246
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Luisenkrankenhaus GmbH & Co. KG
Department Name
Zentrum für Gynäkologische Onkologie Düsseldorf Luisenkrankenhaus GmbH & Co. KG
Contact Person Name
Athina Kostara
Contact Person Email
info@gynonco.de
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
HELIOS Klinikum Berlin-Buch Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Michael Untch
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Frauenheilkunde Department für Frauen- und Kindermedizin
Contact Person Name
Bahriye Aktas
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Evang. Huyssens-Stiftung/Knappschaft GmbH Senologie/ Interdisziplinäres Brustzentrum
Contact Person Name
Jennifer Spönlein
Contact Person Email
senostudien@kem-med.com
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Frauenklinik
Contact Person Name
Peter Fasching
Site Name
Caritas Traegergesellschaft Saarbruecken mbH (CTS)
Department Name
Klinik für Frauenheilkunde/Brustzentrum Saar Mitte
Contact Person Name
Mustafa Deryal

Greece

Earliest CTIS Part Ii Submission Date
08-07-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
283
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Athens Medical Center S.A.
Department Name
3rd Department of Oncology
Contact Person Name
Konstantinos Papazisis
Contact Person Email
k.papazisis@oncomedicare.com
Site Name
General University Hospital Of Larissa
Department Name
Oncology Clinic, Chemotherapy Department
Contact Person Name
Athanasios Kotsakis
Contact Person Email
kotsakisthan@gmail.com
Site Name
Areteio Hospital
Department Name
Oncology Unit, B' Surgery Department
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
University General Hospital Of Heraklion
Department Name
Department of Medical Oncology
Contact Person Name
Dimitrios Mavroudis
Contact Person Email
medoncsec@med.uoc.gr

Belgium

Earliest CTIS Part Ii Submission Date
12-05-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
340
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Az Maria Middelares Gent
Department Name
Integrated Cancer Center Ghent
Contact Person Name
Félix Gremonprez
Site Name
Ziekenhuis Oost Limburg
Department Name
Oncologie
Contact Person Name
Guy Debrock
Contact Person Email
guy.debrock@zol.be
Site Name
Ziekenhuis Aan De Stroom
Department Name
Oncologisch centrum Antwerpen
Contact Person Name
Kevin Punie
Contact Person Email
kevin.punie@zas.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Medical Oncology
Contact Person Name
Eline Naert
Contact Person Email
eline.naert@uzgent.be

Poland

Earliest CTIS Part Ii Submission Date
12-05-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
343
Number Of Sites
9
Number Of Participants
55

Sites

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
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddział Onkologii Klinicznej im. dr E. Pileckiej z Pododdziałem Chemioterapii Dziennej
Contact Person Name
Kinga Hermanowicz-Szamatowicz
Site Name
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Department Name
Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym i Izbą Przyjęć
Contact Person Name
Anna Szafryna-Kliwicka
Contact Person Email
clinicaltrials@wco.pl
Site Name
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Department Name
Poradnia Onkologiczna
Contact Person Name
Sylwina Socha
Site Name
Pratia S.A.
Department Name
Pratia MCM Kraków
Contact Person Name
Aleksandra Grela-Wojewoda
Contact Person Email
biuro.mcm@pratia.com
Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej i Radioterapii
Contact Person Name
Lubomir Bodnar
Contact Person Email
bbk@szpital.siedlce.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej
Contact Person Name
Zbigniew Nowecki
Contact Person Email
nowotworypiersi@nio.gov.pl
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej
Contact Person Name
Iwona Danielewicz
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii I
Contact Person Name
Bogdan Żurawski

Netherlands

Earliest CTIS Part Ii Submission Date
06-05-2025
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
343
Number Of Sites
7
Number Of Participants
12

Sites

Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Internal Medicine
Contact Person Name
Karin Beelen
Contact Person Email
Hverheij@Rijnstate.nl
Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis
Department Name
Internal Medicine
Contact Person Name
Annet Coumou
Contact Person Email
trialbureau-onco@etz.nl
Site Name
Stichting Martini Ziekenhuis
Department Name
Internal Medicine
Contact Person Name
Bart Kuenen
Contact Person Email
wetenschap@mzah.nl
Site Name
Zuyderland Medisch Centrum Stichting
Department Name
Internal Medicine
Contact Person Name
Franchette van den Berkmortel
Site Name
Meander Medisch Centrum
Department Name
Internal Medicine
Contact Person Name
Jara Baas
Site Name
Deventer Ziekenhuis
Department Name
Internal Medicine
Contact Person Name
Wim van Boxtel
Contact Person Email
researchoncologie@dz.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Internal Medicine
Contact Person Name
Agnes Jager
Contact Person Email
a.jager@erasmusmc.nl

Italy

Earliest CTIS Part Ii Submission Date
26-08-2025
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
232
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Istituto Oncologico Veneto
Department Name
Oncologia 2
Contact Person Name
Valentina Guarneri
Contact Person Email
valentina.guarneri@unipd.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Clinica di Oncologia Medica
Contact Person Name
Lucia Del Mastro
Contact Person Email
lucia.delmastro@hsanmartino.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncologia Medica 1
Contact Person Name
Fabio Calabrò
Contact Person Email
fabio.calabro@ifo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Oncologia Medica
Contact Person Name
Alessandra Fabi
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncologia Medica
Contact Person Name
Giampaolo Bianchini
Contact Person Email
bianchini.giampaolo@hsr.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU ONCOLOGIA
Contact Person Name
Alessandra Gennari
Contact Person Email
alessandra.gennari@uniupo.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Struttura Complessa Oncologia Medica 1
Contact Person Name
Giulia Bianchi
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Oncologia Medica
Contact Person Name
Claudio Zamagni
Contact Person Email
zamagniclaudio.sper@aosp.bo.it

France

Earliest CTIS Part Ii Submission Date
13-05-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
339
Number Of Sites
9
Number Of Participants
40

Sites

Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Contact Person Name
Nelly Firmin
Contact Person Email
nelly.firmin@icm.unicancer.fr
Site Name
Centre Henri Becquerel
Department Name
Medical Oncology
Contact Person Name
Marianne Leheurteur
Site Name
HIA Sainte Anne
Department Name
Oncology - Hematology
Contact Person Name
Laurys Boudin
Contact Person Email
laurys84@hotmail.com
Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical Oncology
Contact Person Name
Jean Frenel
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Olivier Tredan
Site Name
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Department Name
Medical Oncology
Contact Person Name
Audrey Simonaggio
Contact Person Email
asimonaggio@ghpsj.fr
Site Name
Institut Godinot
Department Name
Medical Oncology
Contact Person Name
Amélie Lemoine
Site Name
Assistance Publique Hopitaux De Paris
Department Name
FIH / Phase I Unit
Contact Person Name
Jacques Medioni
Contact Person Email
jacques.medioni@aphp.fr
Site Name
Polyclinique De Limoges
Department Name
Medical Oncology
Contact Person Name
Dominique Genet
Contact Person Email
d.genet@imro.fr

Finland

Earliest CTIS Part Ii Submission Date
09-09-2025
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
217
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
HUS-yhtymae
Department Name
Comprehensive Cancer Center
Contact Person Name
Peeter Karihtala
Contact Person Email
peeter.karihtala@hus.fi
Site Name
Oulu University Hospital
Department Name
Cancer Center
Contact Person Name
Sanna Iivanainen
Contact Person Email
sanna.iivanainen@pohde.fi
Site Name
Tampere University Hospital
Department Name
Department of Oncology
Contact Person Name
Minna Tanner
Contact Person Email
minna.tanner@pirha.fi

Czechia

Earliest CTIS Part Ii Submission Date
09-09-2025
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
217
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Onkologicka klinika
Contact Person Name
Martina Zimovjanová
Contact Person Email
martina.zimovjanova@vfn.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Onkologicka klinika
Contact Person Name
Jakub Cvek
Contact Person Email
jakub.cvek@fno.cz
Site Name
University Hospital Olomouc
Department Name
Onkologicka klinika
Contact Person Name
Bohuslav Melichar
Contact Person Email
Bohuslav.Melichar@fnol.cz
Site Name
Fakultni Nemocnice Motol A Homolka
Department Name
Onkologicka klinika 2. LF UK a FN Motol
Contact Person Name
Tomas Buchler
Contact Person Email
tomas.buchler@fnmotol.cz
Site Name
Fakultni Thomayerova nemocnice
Department Name
Onkologicka klinika
Contact Person Name
Eugen Kubala
Contact Person Email
eugen.kubala@ftn.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexni onkologicke pece
Contact Person Name
Anna Krásenská
Contact Person Email
anna.krasenska@mou.cz

Hungary

Earliest CTIS Part Ii Submission Date
14-08-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
246
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
University Of Debrecen
Department Name
Onkológiai Klinika
Contact Person Name
Péter Árkosy
Contact Person Email
arkosy.peter@med.unideb.hu
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
Onkológiai Központ
Contact Person Name
László Torday
Contact Person Email
laszlo.torday@gmail.com
Site Name
Budapesti Uzsoki Utcai Korhaz
Department Name
Onkoradiológiai Osztály
Contact Person Name
Edina Mészáros
Contact Person Email
m.edina@uzsoki.hu
Site Name
Semmelweis Egyetem
Department Name
Onkológiai Profil
Contact Person Name
Gyöngyvér Szentmártoni
Contact Person Email
gyszentmartoni@gmail.com
Site Name
University Of Szeged
Department Name
Onkoterápiás Klinika
Contact Person Name
Alíz Nikolényi
Contact Person Email
nikolenyi.aliz@gmail.com
Site Name
Orszagos Onkologiai Intezet
Department Name
“B” Belgyógyászati-Onkológiai Osztály és Klinikai Farmakológiai Osztály
Contact Person Name
Balázs Madaras
Contact Person Email
madaras.balazs@oncol.hu

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Public Limited Company
Responsibilities
Central imaging
Name
Parexel International Corp.
Responsibilities
Medical information (Physician Consulting)
Name
Icon Laboratory Services Inc.
Responsibilities
Laboratory services (sponsor duties code 4)
Name
Signant Health Global Solutions Limited
Responsibilities
ePRO and other electronic data capture/support (sponsor duties include ePRO)

Third parties

  • {"country":"Germany","full_name":"Roche Diagnostics GmbH","duties_or_roles":"[{\"id\":900589,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"[{\"id\":900586,\"code\":\"15\",\"value\":\"ePRO\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"[{\"id\":900588,\"code\":\"3\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Public Limited Company","duties_or_roles":"[{\"id\":900585,\"code\":\"15\",\"value\":\"Central imaging\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"[{\"id\":900587,\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"[{\"id\":900590,\"code\":\"15\",\"value\":\"Medical information (Physician Consulting)\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"[{\"id\":900591,\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
MK-2870
Active Substance
SACITUZUMAB TIRUMOTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
No marketing authorisation listed (investigational product)
Maximum Dose
4 mg/kg
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Marketing authorisation EU/1/15/1024/002
Maximum Dose
600 mg
Combination Treatment
Yes

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