Clinical trial • Phase III • Oncology

PETOSEMTAMAB for Head and neck squamous cell carcinoma | Recurrent/metastatic head and neck squamous cell carcinoma

Phase III trial of PETOSEMTAMAB for Head and neck squamous cell carcinoma | Recurrent/metastatic head and neck squamous cell carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Head and neck squamous cell carcinoma | Recurrent/metastatic head and neck squamous cell carcinoma
Trial Stage
Phase III
Drug Modality
Other antibody | Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
19-04-2024
First CTIS Authorization Date
27-08-2024

Trial design

Randomised, open-label, investigator’s choice monotherapy including (examples provided): methotrexate 25 mg/ml solution for injection (methotrexate; max daily dose reported 60 mg/m2), erbitux 5 mg/ml solution for infusion (cetuximab; max daily dose reported 400 mg/m2), docetaxel ever valinject 20 mg/ml concentrate for infusion (docetaxel; max daily dose reported 40 mg/m2).-controlled Phase III trial in Belgium, Germany, Netherlands and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigator’s choice monotherapy including (examples provided): Methotrexate 25 mg/ml solution for injection (Methotrexate; max daily dose reported 60 mg/m2), Erbitux 5 mg/mL solution for infusion (Cetuximab; max daily dose reported 400 mg/m2), Docetaxel EVER Valinject 20 mg/ml concentrate for infusion (Docetaxel; max daily dose reported 40 mg/m2).
Target Sample Size
215

Eligibility

Recruits 215 Participants must be able to provide their own informed consent. "Willing and able to provide signed ICF before initiation of any study procedures. Participants unable to provide their own consent will not be eligible to participate in the study.".

Pregnancy Exclusion
13. Pregnant or breastfeeding participants
Vulnerable Population
Participants must be able to provide their own informed consent. "Willing and able to provide signed ICF before initiation of any study procedures. Participants unable to provide their own consent will not be eligible to participate in the study."

Inclusion criteria

  • {"criterion_text":"- 1.\tWilling and able to provide signed ICF before initiation of any study procedures. Participants unable to provide their own consent will not be eligible to participate in the study."}
  • {"criterion_text":"- 8.\tThe participant is amenable for a new tumor biopsy or providing archival tumor tissue."}
  • {"criterion_text":"- 9. Measurable disease per Investigator assessment as defined by RECIST v1.1 by radiologic methods"}
  • {"criterion_text":"- 12. Adequate organ function (as per protocol)"}
  • {"criterion_text":"- 13. Human immunodeficiency virus (HIV)-positive participants."}
  • {"criterion_text":"- 14. Judged appropriate by the Investigator to receive Investigator’s choice monotherapy, if randomized to that treatment arm."}
  • {"criterion_text":"- 10. ECOG PS of 0 or 1"}
  • {"criterion_text":"- 11. Life expectancy ≥ 12 weeks, as per investigator"}
  • {"criterion_text":"- 2. Age ≥ 18 years at signing of ICF"}
  • {"criterion_text":"- 3. Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent."}
  • {"criterion_text":"- 4.\tHNSCC participants progressed on or after anti-PD-1 therapy and platinum-containing therapy."}
  • {"criterion_text":"- 5. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx."}
  • {"criterion_text":"- 6.\tDocumentation of p16 status (positive or negative) by local laboratory IHC for participants with primary oropharyngeal cancer must be available before further clinical assessment to determine eligibility."}
  • {"criterion_text":"- 7. Previous treatments with anti-EGFR therapies are not allowed, unless cetuximab was used with radiotherapy as a multimodal treatment of local disease and the recurrence/progression of the disease was ≥1 year from the last dose of cetuximab"}

Exclusion criteria

  • {"criterion_text":"- 1. Metastasen in het centraal zenuwstelsel die onbehandeld of symptomatisch zijn, of bestraling, een operatie of voortzetting van steroïdentherapie nodig hebben om de symptomen onder controle te houden binnen 14 dagen vóór randomisatie"}
  • {"criterion_text":"- 10.\tCurrent dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy. History of non-infectious pneumonitis/instestitial lung disease or evidence of current interstitial lung disease on baseline scan"}
  • {"criterion_text":"- 11. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders"}
  • {"criterion_text":"- 12.\tParticipants with known infectious diseases (as per protocol)"}
  • {"criterion_text":"- 13.\tPregnant or breastfeeding participants"}
  • {"criterion_text":"- 14.\tParticipant has a primary tumor site of nasopharynx, or sinonasal (any histology)."}
  • {"criterion_text":"- 2. Known leptomeningeal involvement"}
  • {"criterion_text":"- 3. Enrolled in any clinical study with petosemtamab, regardless if petosemtamab was received or not"}
  • {"criterion_text":"- 4.\tAny systemic anticancer therapy investigational drug (including those with indications other than anticancer therapy), or live or live attenuated vaccine within 4 weeks or 5 half-lives (if known), whichever is shorter, prior to randomization"}
  • {"criterion_text":"- 5. Major surgery within 3 weeks prior to randomization or palliative radiotherapy within 2 weeks prior to randomization"}
  • {"criterion_text":"- 6. Clinically significant toxicities related to prior antineoplastic therapies that have not returned to ≤ Grade 1 or baseline except for alopecia, and ≤ Grade 2 prior therapy-related endocrinopathies"}
  • {"criterion_text":"- 7. History of hypersensitivity reaction to any of the excipients of treatment required for this study."}
  • {"criterion_text":"- 8.\tUnstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months prior to randomization"}
  • {"criterion_text":"- 9.\tHistory of prior malignancies within the last 5 years except for localized cancer with curative resection (e.g., cervical intraepithelial neoplasia, non-melanoma skin cancers)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"To compare overall survival (OS) in participants with incurable metastatic / recurrent HNSCC who progressed on or after anti-programmed cell death protein 1 (PD-1) and platinum containing therapy, treated with petosemtamab monotherapy vs Investigator’s choice monotherapy"}

Secondary endpoints

  • {"endpoint_text":"- 2. Progression Free Survival PFS per RECIST v1.1 as assessed by BICR","definition_or_measurement_approach":"Progression-Free Survival per RECIST v1.1 as assessed by Blinded Independent Central Review (BICR)"}
  • {"endpoint_text":"- 3. DOR per RECIST v1.1 as assessed by BICR","definition_or_measurement_approach":"Duration of Response per RECIST v1.1 as assessed by BICR"}
  • {"endpoint_text":"- 4. ORR per RECIST v1.1 as assessed by investigator review","definition_or_measurement_approach":"Objective Response Rate per RECIST v1.1 as assessed by Investigator review"}
  • {"endpoint_text":"- 5. PFS per RECIST v1.1 as assessed by investigator review","definition_or_measurement_approach":"Progression-Free Survival per RECIST v1.1 as assessed by Investigator review"}
  • {"endpoint_text":"- 6. DOR per RECIST v1.1 as assessed by investigator review","definition_or_measurement_approach":"Duration of Response per RECIST v1.1 as assessed by Investigator review"}
  • {"endpoint_text":"- 7. TTR per RECIST v1.1 as assessed by BICR and by Investigator review","definition_or_measurement_approach":"Time to Response per RECIST v1.1 as assessed by both BICR and Investigator review"}
  • {"endpoint_text":"- 8. CBR per RECIST v1.1 as assessed by BICR and by Investigator review","definition_or_measurement_approach":"Clinical Benefit Rate per RECIST v1.1 as assessed by BICR and Investigator review"}
  • {"endpoint_text":"- 9. Proportion of participants experiencing TEAEs","definition_or_measurement_approach":"Proportion of participants experiencing treatment-emergent adverse events (TEAEs)"}
  • {"endpoint_text":"- 10. Proportion of participants experiencing serious TEAEs","definition_or_measurement_approach":"Proportion of participants experiencing serious treatment-emergent adverse events"}
  • {"endpoint_text":"- 11. Proportion of participants who discontinued study treatment due to TEAEs","definition_or_measurement_approach":"Proportion of participants who discontinued study treatment because of TEAEs"}
  • {"endpoint_text":"- 12. Proportion of participants who had dose reductions due to TEAEs","definition_or_measurement_approach":"Proportion of participants who had dose reductions due to TEAEs"}
  • {"endpoint_text":"- 1. Objective response rate (ORR) per RECIST v1.1 as assessed by BICR.","definition_or_measurement_approach":"Objective Response Rate per RECIST v1.1 as assessed by Blinded Independent Central Review (BICR)"}

Recruitment

Planned Sample Size
215
Recruitment Window Months
42
Consent Approach
Participants must be ≥18 years and must be willing and able to provide signed informed consent prior to any study procedures. "Willing and able to provide signed ICF before initiation of any study procedures. Participants unable to provide their own consent will not be eligible to participate in the study." Informed consent documents (SIS/ICF) are available in multiple languages (including English, French, Dutch, German, Greek, Spanish, Italian, Polish, Czech, Hungarian, Lithuanian, Portuguese) per the ICF/SIS documents listed in the submission.

Geography

Total Number Of Sites
80
Total Number Of Participants
336

Belgium

Earliest CTIS Part Ii Submission Date
15-07-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
602
Number Of Sites
6
Number Of Participants
25

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Medical Oncology
Contact Person Name
Michael Saerens
Contact Person Email
michael.saerens@uzgent.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Contact Person Name
Jean-Pascal Machiels
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Oncology
Contact Person Name
Stéphanie Henry
Site Name
Institut Jules Bordet
Department Name
Oncology
Contact Person Name
Yassine Lalami
Contact Person Email
yassine.lalami@hubruxelles.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Medical Oncology
Contact Person Name
Aurélie Poncin
Contact Person Email
aponcin@chuliege.be
Site Name
Katholieke Universiteit te Leuven
Department Name
Medical Oncology
Contact Person Name
Paul Clement
Contact Person Email
paul.clement@uzleuven.be

Germany

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
584
Number Of Sites
13
Number Of Participants
20

Sites

Site Name
Universitaet Leipzig
Department Name
Klinik für Hals,-Nasen- und Ohrenheilkunde
Contact Person Name
Andreas Dietz
Site Name
Universitaetsklinikum Essen AöR
Department Name
Department of medical oncology
Contact Person Name
Michael Pogorzelski
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Department for Otorhinolaryngology, Head and Neck Surgery
Contact Person Name
Barbara Wollenberg
Contact Person Email
barbara.wollenberg@tum.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Hals-, Nasen- und Ohrenklink
Contact Person Name
Christine Langer
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Hämatologie, Hämostaseologie, Onkologie Und Stammzelltransplantation
Contact Person Name
Philipp Ivanyi
Contact Person Email
Ivanyi.Philipp@mh-hannover.de
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf-und Halschirurgie
Contact Person Name
Markus Blaurock
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Asklepios Klinik Altona Abteilung Onkologie, Hämatologie
Contact Person Name
Dirk Arnold
Contact Person Email
d.arnold@asklepios.com
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie
Contact Person Name
Konrad Klinghammer
Contact Person Email
konrad.klinghammer@charite.de
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Department of Otorhinolaryngology, Head and Neck Surgery, Experimental Head and Neck Oncology
Contact Person Name
Annette Affolter
Contact Person Email
annette.affolter@umm.de
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Fakultät, Medizinische Klinik I, Studienzentrale internistische Onkologie
Contact Person Name
Ulrike Ubbelohde
Contact Person Email
oncostudy@ukdd.de
Site Name
Universitaet Muenster
Department Name
ENT Clinic
Contact Person Name
Achim Georg Beule
Contact Person Email
AchimGeorg.Beule@ukmuenster.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Zentrum für Onkologie
Contact Person Name
Philippe Schafhausen
Contact Person Email
schafhausen@uke.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Interdisziplinäres Studienzentrum (ISZ) mit ECTU
Contact Person Name
Urs Müller-Richter
Contact Person Email
mueller_u2@ukw.de

Netherlands

Earliest CTIS Part Ii Submission Date
22-07-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
595
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Oncology
Contact Person Name
Jan Paul de Boer
Contact Person Email
j.d.boer@nki.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Oncology
Contact Person Name
Lot Devriese
Contact Person Email
l.a.devriese@umcutrecht.nl
Site Name
Stichting Radboud universitair medisch centrum
Department Name
Oncology
Contact Person Name
Carla van Herpen
Contact Person Email
carla.vanherpen@radboudumc.nl

Lithuania

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
150
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Nacionalinis vezio institutas
Department Name
Chemotherapy Day Inpatient Unit
Contact Person Name
Giedre Anglickiene
Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Department of Oncology and Hematology
Contact Person Name
Viktoras Rudzianskas

Poland

Earliest CTIS Part Ii Submission Date
16-07-2024
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
668
Number Of Sites
8
Number Of Participants
25

Sites

Site Name
Beskidzkie Centrum Onkologii Szpital Miejski Im. Jana Pawla II W Bielsku-Bialej SPZOZ
Department Name
Oddział Radioterapii i Chemioterapii
Contact Person Name
Maciej Pysz
Contact Person Email
mpysz@poczta.onet.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Żurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Krzysztof Konopa
Contact Person Email
konopa@gumed.edu.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Zakład Teleradioterapii i Oddział Chorób Rozrostowych
Contact Person Name
Jacek Fijuth
Contact Person Email
jacekf@kopernik.lodz.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Gliwice)
Department Name
Centrum Wsparcia Badań Klinicznych
Contact Person Name
Tomasz Rutkowski
Site Name
Pratia S.A. (Poznan)
Department Name
Pratia Poznań
Contact Person Name
Marek Kotlarski
Contact Person Email
marek.kotlarski@pratia.com
Site Name
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Dziennym
Contact Person Name
Anna Kowalczyk-Tekiela
Contact Person Email
atekiela@interia.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
Department Name
Klinika Nowotworów Głowy i Szyi
Contact Person Name
Andrzej Kawecki
Contact Person Email
andrzej.kawecki@nio.gov.pl

France

Earliest CTIS Part Ii Submission Date
06-06-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
706
Number Of Sites
16
Number Of Participants
80

Sites

Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Medical Oncology
Contact Person Name
Victor Sarradin
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Medical Oncology
Contact Person Name
Amaury Daste
Contact Person Email
amaury.daste@chu-bordeaux.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Medical Oncology
Contact Person Name
Sébastien Salas
Contact Person Email
sebastien.salas@ap-hm.fr
Site Name
Institut De Cancerologie De Lorraine
Department Name
Oncologie médicale
Contact Person Name
Camille JAUD
Contact Person Email
c.jaud@nancy.unicancer.fr
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Medical Oncology
Contact Person Name
Loïc JAFFRELOT
Contact Person Email
loic.jaffrelot@aphp.fr
Site Name
Centre Henri Becquerel
Department Name
Medical Oncology
Contact Person Name
Florian Clatot
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Jérôme Fayette
Site Name
Centre Antoine Lacassagne
Department Name
Medical Oncology
Contact Person Name
Esma SAADA-BOUZID
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Medical Oncology
Contact Person Name
Pierre LE NOAC'H
Contact Person Email
pierre.lenoach@chu-brest.fr
Site Name
Centre Oscar Lambret
Department Name
Medical Oncology
Contact Person Name
Cyril Abdeddaim
Contact Person Email
c-abdeddaim@o-lambret.fr
Site Name
Institut Gustave Roussy
Department Name
Medical Oncology
Contact Person Name
Caroline Even
Contact Person Email
caroline.even@gustaveroussy.fr
Site Name
Clinique Victor Hugo (Le Mans)
Department Name
Medical Oncology
Contact Person Name
Yoann Pointreau
Contact Person Email
essaispointreau@ilcgroupe.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis (Rennes)
Department Name
ENT, Neurooncology, Urology
Contact Person Name
Antonin BROYELL
Contact Person Email
a.broyelle@rennes.unicancer.fr
Site Name
Institut Curie
Department Name
Medical Oncology
Contact Person Name
Edith Borcoman
Contact Person Email
edith.borcoman@curie.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Contact Person Name
Thibault Mazard
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis (Poitiers?)
Department Name
Medical oncology
Contact Person Name
Camille EVRARD
Contact Person Email
camille.evrard@chu-poitiers.fr

Spain

Earliest CTIS Part Ii Submission Date
16-06-2024
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
697
Number Of Sites
9
Number Of Participants
30

Sites

Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Luka Mihic Gongora
Contact Person Email
lmihic@hmhospitales.com
Site Name
Hospital Clinico San Carlos
Department Name
Medical Oncology
Contact Person Name
Santiago Cabezas-Camarero
Site Name
Hospital Quironsalud Barcelona
Department Name
Medical Oncology
Contact Person Name
Roxana Reyes Cabanillas
Contact Person Email
nvelazquez@i-crom.net
Site Name
Hospital Universitario De Navarra
Department Name
Oncology
Contact Person Name
Virginia Arrazubi Arrula
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Contact Person Name
Jose Maria Lopez-Picazo Gonzalez
Contact Person Email
jlpicazo@unav.es
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Contact Person Name
Hector Augusto Aguilar Andino
Contact Person Email
hagilar@fivo.org
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Imanol Martinez Salas
Contact Person Email
imanol.martinez@quironsalud.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Katerin Ingrid Rojas Laimito
Contact Person Email
krojas@vhio.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Lara Iglesias Docampo

Italy

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
681
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
Unit of Oncology and Hematology
Contact Person Name
Paolo Bossi
Contact Person Email
paolo.bossi@hunimed.eu
Site Name
Azienda Ospedaliera Santa Croce E Carle
Department Name
Oncology
Contact Person Name
Giacomo Aimar
Contact Person Email
aimar.g@ospedale.cuneo.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Oncology
Contact Person Name
Alessio Cirillo
Contact Person Email
alessio.cirillo@uniroma1.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Medical Oncology Unit
Contact Person Name
Andrea Alberti
Contact Person Email
a.alberti015@unibs.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
oncologist
Contact Person Name
Francesco Perri
Contact Person Email
f.perri@istitutotumori.na.it
Site Name
Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Oncology
Contact Person Name
Morena Fasano
Contact Person Email
morena.fasano@unicampania.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Oncologia Medica Urogenitale e Cervico Facciale
Contact Person Name
Maria Cossu Rocca
Contact Person Email
maria.cossurocca@ieo.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncology
Contact Person Name
Lisa Francesca Linda Licitra

Portugal

Earliest CTIS Part Ii Submission Date
18-08-2025
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
266
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Unidade Local de Saude do Algarve E.P.E.
Department Name
Serviço de oncologia médica
Contact Person Name
Ana Varges Gomes
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Medical Oncology Department
Contact Person Name
Cláudia Vieira
Site Name
Hospital Cuf Descobertas S.A.
Department Name
Oncology department
Contact Person Name
Diogo Costa
Contact Person Email
diogo.costa@cuf.pt
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Oncology department
Contact Person Name
Leonor Pinto
Contact Person Email
10331@ulscoimbra.min-saude.pt

Greece

Earliest CTIS Part Ii Submission Date
08-05-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
735
Number Of Sites
5
Number Of Participants
45

Sites

Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Propaedeutic Internal Medicine Clinic(P.C -12462)
Contact Person Name
Amanda Psyrri
Contact Person Email
psyrri237@yahoo.com
Site Name
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.
Department Name
1st Department of Medical Oncology
Contact Person Name
Athanasios Argyris
Contact Person Email
argirisoncology@gmail.com
Site Name
St. Luke's Hospital S.A.
Department Name
Department of Medical Oncology
Contact Person Name
Eleni Fountzila
Contact Person Email
info@klinikiagiosloukas.gr
Site Name
General University Hospital Of Patras
Department Name
Division of Oncology, Department of Medicine
Contact Person Name
Angelos Koutras
Contact Person Email
angkoutr@otenet.gr
Site Name
University General Hospital Of Heraklion
Department Name
Department of Medical Oncology
Contact Person Name
Sofia Agelaki
Contact Person Email
agelaki@uoc.gr

Czechia

Earliest CTIS Part Ii Submission Date
30-09-2025
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
225
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Fakultni Nemocnice Motol A Homolka
Department Name
Onkologická klinika
Contact Person Name
Michaela Jirkovská
Contact Person Email
michaela.jirkovska@fnmotol.cz
Site Name
University Hospital Olomouc
Department Name
Onkologická klinika
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Komplexní onkologické centrum, Oddělení onkologie a radioterapie
Contact Person Name
Vojtěch Tlustý
Contact Person Email
vojtech.tlusty@nnj.agel.cz

Hungary

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
240
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
University Of Szeged
Department Name
Onkoterápiás Klinika
Contact Person Name
Melinda Csenki-Lalia
Contact Person Email
drcsenkimelinda@gmail.com
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Onkoradiológia
Contact Person Name
Ágnes Wéber
Contact Person Email
agneswebermed@gmail.com
Site Name
University Of Pecs
Department Name
Onkoterápiás Intézet
Contact Person Name
Szabolcs Bellyei
Contact Person Email
bellyeisz@gmail.com

Sponsor

Primary sponsor

Full Name
Merus N.V.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Netherlands

Contract research organisations

Name
Medpace Finland Oy
Responsibilities
Sponsor/operational duties (sponsorDuties codes: 1,12,13,2,5,6 as listed)
Name
Medpace Ellas Monoprosopi I.K.E.
Responsibilities
Sponsor/operational duties (sponsorDuties codes: 1,12 as listed)
Name
QPS Netherlands B.V.
Responsibilities
Vendor/CRO functions (sponsorDuties codes: 4)

Third parties

  • {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"sponsorDuties codes: 1,12,13,2,5,6 (as listed in submission)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"sponsorDuties codes: 15 (genetic testing), 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"QPS Netherlands B.V.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Median Technologies","duties_or_roles":"sponsorDuties codes: 15 (central imaging), 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"Medpace Ellas Monoprosopi I.K.E.","duties_or_roles":"sponsorDuties codes: 1,12","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Discovery Life Sciences Biomarker Services GmbH","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Almac Pharma Services (Ireland) Limited","duties_or_roles":"sponsorDuties codes: 15 (IP packaging), 3","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Petosemtamab (MCLA-158)
Active Substance
PETOSEMTAMAB
Modality
Other antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
maxDailyDoseAmount 1500 mg (as listed)
Investigational Product Name
Erbitux 5 mg/mL solution for infusion (Cetuximab) - comparator
Active Substance
CETUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Marketing authorisation EU/1/04/281/003 (prodAuthStatus 2)
Maximum Dose
maxDailyDoseAmount 400 mg/m2 (as listed)
Investigational Product Name
Docetaxel EVER Valinject 20 mg/ml (Docetaxel) - comparator
Active Substance
DOCETAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
marketingAuthNumber 2200092.00.00 (prodAuthStatus 2)
Maximum Dose
maxDailyDoseAmount 40 mg/m2 (as listed)
Investigational Product Name
Methotrexate 25 mg/ml solution for injection - comparator
Active Substance
METHOTREXATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
marketingAuthNumber PL 20075/0344 (prodAuthStatus 2)
Maximum Dose
maxDailyDoseAmount 60 mg/m2 (as listed)

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