Clinical trial • Phase III • Oncology

XALURITAMIG for Metastatic castration-resistant prostate cancer

Phase III trial of XALURITAMIG for Metastatic castration-resistant prostate cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic castration-resistant prostate cancer
Trial Stage
Phase III
Drug Modality
Bispecific antibody|Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
02-12-2024
First CTIS Authorization Date
07-04-2025

Trial design

Randomised, open-label, investigator’s choice control arm: cabazitaxel (intravenous chemotherapy) or second androgen receptor-directed therapy (ardt) such as enzalutamide or abiraterone acetate as determined by investigator prior to randomization; specific doses and schedules not specified in the provided record. Phase III trial in Austria, Belgium, Denmark and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigator’s choice control arm: cabazitaxel (intravenous chemotherapy) OR second androgen receptor-directed therapy (ARDT) such as enzalutamide or abiraterone acetate as determined by investigator prior to randomization; specific doses and schedules not specified in the provided record.
Target Sample Size
331
Trial Duration For Participant
1729

Eligibility

Recruits 331 No vulnerable populations are selected. Subjects must provide informed consent prior to any study-specific activities/procedures; age eligibility is ≥18 years (or legal age if older in the country). Only male subjects are enrolled (isMaleSubjects true, isFemaleSubjects false). Country-specific subject information and informed consent forms (including optional genetics and pregnancy follow-up forms) are provided..

Vulnerable Population
No vulnerable populations are selected. Subjects must provide informed consent prior to any study-specific activities/procedures; age eligibility is ≥18 years (or legal age if older in the country). Only male subjects are enrolled (isMaleSubjects true, isFemaleSubjects false). Country-specific subject information and informed consent forms (including optional genetics and pregnancy follow-up forms) are provided.

Inclusion criteria

  • {"criterion_text":"-Subject has provided informed consent(s) prior to initiation of any study specific activities/procedures."}
  • {"criterion_text":"-Prior treatment with only one taxane therapy in mCRPC setting. Note: Prior treatment with docetaxel in the mHSPC setting is permitted; however, subjects must have also received one, and only one, taxane therapy in the mCRPC setting."}
  • {"criterion_text":"-Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1"}
  • {"criterion_text":"-Adequate organ function"}
  • {"criterion_text":"-Age equal or greater than 18 years (or equal or greater than legal age within the country if it is older than 18 years) at the time of signing the informed consent"}
  • {"criterion_text":"-Subject must have histological, pathological and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg,adenocarcinoma with neuroendocrine component) are not permitted."}
  • {"criterion_text":"-mCRPC with equal or greater than 1 metastatic lesion that is present on baseline computed tomography, magnetic resonance imaging, or bone scan imaging obtained within 28 days prior to enrollment."}
  • {"criterion_text":"-Evidence of progressive disease, defined as 1 or more PCWG3 criteria"}
  • {"criterion_text":"-Subjects must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (less than 50 ng/dL or ;ess than 1.7 nmol/L). This must be assessed locally for eligibility"}
  • {"criterion_text":"-Prior progresion on at least one ARDT (enzalutamide, abiraterone, apalutamide, darolutamide)"}

Exclusion criteria

  • {"criterion_text":"-Prior STEAP1-targeted therapy"}
  • {"criterion_text":"-Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks prior to first dose of study treatment, with the following exceptions: -\tAndrogen receptor pathway inhibitors (ARPIs; abiraterone, enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment. -\tAndrogen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotropin-releasing hormone [LHRH/GnRH] analogue, agonist, or antagonist) is permitted."}
  • {"criterion_text":"-Prior PSMA RLT within 2 months of first dose of study treatment unless subjects received less than 2 cycles of therapy. Subjects who received 1 cycle of PSMA RLT within 35 days prior to first dose of study treatment are also excluded."}
  • {"criterion_text":"-Prior pallative radiotherapy within 2 weeks of first dose of study treatment. Subject must have recovered from all radiation-related toxicities."}
  • {"criterion_text":"-Concurrent cytotoxic chemotherapy, ARDT, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, investigational therapy. Note: Prior treatment with a PARP inhibitor is permitted as long as not within 4 weeks before first dose of study treatment."}
  • {"criterion_text":"-Patients with a history of central nervous system (CNS) metastasis. Note: Subjects with treated, asymptomatic, and clinically stable dural metastases are eligible."}
  • {"criterion_text":"-Unresolved toxicities from prior anti-tumor therapy with Common Terminology Criteria for Adverse Events version 5.0 events grade above 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Overall survival","definition_or_measurement_approach":"To compare overall survival (OS) in subjects receiving xaluritamig vs investigator’s choice (cabazitaxel or second androgen receptor-directed therapy [ARDT])"}

Secondary endpoints

  • {"endpoint_text":"-Radiographic progression-free survival per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1, as assessed by blinded independent central review (BICR)","definition_or_measurement_approach":"Per PCWG3-modified RECIST v1.1, assessed by blinded independent central review (BICR)"}
  • {"endpoint_text":"-Objective response per modified RECIST v1.1, as assessed by BICR","definition_or_measurement_approach":"Objective response per modified RECIST v1.1, assessed by BICR"}
  • {"endpoint_text":"-Duration of response (DOR) per RECIST v1.1, as assessed by BICR","definition_or_measurement_approach":"Duration of response per RECIST v1.1, assessed by BICR"}
  • {"endpoint_text":"-Disease control per modified RECIST v 1.1 as assessed by BICR","definition_or_measurement_approach":"Disease control per modified RECIST v1.1, assessed by BICR"}
  • {"endpoint_text":"-Time to Response (TTR) per modified RECIST v1.1, as assessed by BICR","definition_or_measurement_approach":"Time to Response per modified RECIST v1.1, assessed by BICR"}
  • {"endpoint_text":"-Time to first symptomatic skeletal events","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Treatment Emergent Adverse Events, Treatment Emergent Serious Adverse Events, and fatal adverse events","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Change from baseline in: - Brief Pain Inventory - Short Form Worst pain score - BPI-SF Pain intensity scale - BPI-SF Pain interference scale - Functional Assessment of Cancer Therapy – Prostate Total score and subscale scores - European Quality of Life - 5 Domain 5 Level Scale Utility score - Change from baseline in the EQ-5D-5L Visual Analogue Scale","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Time to worsening in: - Brief Pain Inventory - Short Form Worst pain score - Brief Pain Inventory - Short Form Pain intensity scale - Brief Pain Inventory - Short Form Pain interference scale - Functional Assessment of Cancer Therapy – Prostate Total score","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Time to pain improvement in: - Subjects with moderate/severe pain at baseline","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Time to improvement after worsening in: - Brief Pain Inventory - Short Form Pain intensity scale - Brief Pain Inventory - Short Form Pain interference scale","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Patient-reported outcomes summary scores as assessed by: -Selected question on symptomatic adverse events from the Patient-Reported Outcomes version of the Common Terminology Criteria Adverse Events (PRO-CTCAE) item library -The GP5 question on overall bother of side effects from the Functional Assessment of Cancer Therapy – Prostate questionnaire","definition_or_measurement_approach":""}
  • {"endpoint_text":"-PSA50 and PSA90 responses","definition_or_measurement_approach":""}
  • {"endpoint_text":"-PK parameters for xaluritamig such as maximum serum concentration (Cmax), time to maximum concentration (Tmax), minimum serum concentration (Cmin), area under the concentration-time curve (AUC) over the dosing interval, accumulation following multiple dosing, and, if feasible, half-life","definition_or_measurement_approach":"Characterize pharmacokinetics using intensive and sparse PK sampling"}
  • {"endpoint_text":"-Incidence of anti-xaluritamig antibody formation","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
331
Recruitment Window Months
56
Consent Approach
Participants must provide informed consent(s) prior to any study-specific activities/procedures. Only adults (≥18 years or legal age in country) are eligible and provide consent. Country-specific Subject Information Sheets and Informed Consent Forms are provided in multiple languages (examples in the dossier include English, Spanish, French, German, Dutch, Greek, Polish, Italian, Swedish and Arabic), with additional optional consents for genetics research and pregnancy/infant follow-up where applicable.

Methods

  • Study website — study website renditions and translated website text are included in recruitment materials (Study Website English FP and translated texts).
  • Printed recruitment materials — recruitment posters, study introduction trifolds, patient wallet card and recruitment posters used for patient-facing recruitment.
  • HCP outreach — HCP referral letters and HCP guides to support clinician referral for potential participants.
  • Patient information materials — 'Understanding Clinical Studies' booklets and infographics provided to help patients understand the trial.
  • Digital ePRO/eDiary/eCOA — ePRO/eDiary solutions provided (Signant Health listed as ePRO vendor & eDiary) to capture patient-reported data and support remote data collection.
  • Country-specific recruitment packs — multiple country-specific recruitment materials (translated posters, trifolds, website text and local informed consent procedures) are included for national roll-out

Geography

Total Number Of Sites
85
Total Number Of Participants
344

Austria

Earliest CTIS Part Ii Submission Date
21-01-2025
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
356
Number Of Sites
7
Number Of Participants
24

Sites

Site Name
Medical University Of Graz
Department Name
Oncology Department
Principal Investigator Name
Thomas Bauernhofer
Principal Investigator Email
thomas.bauernhofer@medunigraz.at
Contact Person Name
Thomas Bauernhofer
Site Name
Krankenhaus Der Barmherzigen Brueder Wien
Department Name
Department of Internal Medicine II
Principal Investigator Name
Johannes Meran
Principal Investigator Email
johannes.meran@bbwien.at
Contact Person Name
Johannes Meran
Contact Person Email
johannes.meran@bbwien.at
Site Name
Medical University Of Vienna
Department Name
Department of Urology
Principal Investigator Name
Gero Kramer
Principal Investigator Email
gero.kramer@meduniwien.ac.at
Contact Person Name
Gero Kramer
Contact Person Email
gero.kramer@meduniwien.ac.at
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
Department of Internal Medicine I
Principal Investigator Name
Hossein Taghizadeh
Principal Investigator Email
hossein.taghizadeh@stpoelten.lknoe.at
Contact Person Name
Hossein Taghizadeh
Site Name
Ordensklinikum Linz GmbH
Department Name
Department of Urology and Andrology
Principal Investigator Name
Andreas Reichinger
Principal Investigator Email
andreas.reichinger@ordensklinikum.at
Contact Person Name
Andreas Reichinger
Site Name
Medizinische Universitaet Innsbruck
Department Name
Department of Urology
Principal Investigator Name
Isabel Maria Heidegger-Pircher
Principal Investigator Email
isabel-maria.heidegger@i-med.ac.at
Contact Person Name
Isabel Maria Heidegger-Pircher
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Department of Internal Medicine III
Principal Investigator Name
Simon Gampenrieder
Principal Investigator Email
s.gampenrieder@salk.at
Contact Person Name
Simon Gampenrieder
Contact Person Email
s.gampenrieder@salk.at

Belgium

Earliest CTIS Part Ii Submission Date
11-03-2025
Latest Decision Or Authorization Date
30-01-2026
Processing Time Days
325
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Centre Hospitalier Universitaire De Liege
Department Name
Medical Oncology
Principal Investigator Name
Brieuc Sautois
Principal Investigator Email
brieuc.sautois@chuliege.be
Contact Person Name
Brieuc Sautois
Contact Person Email
brieuc.sautois@chuliege.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Medical Oncology
Principal Investigator Name
Sylvie Rottey
Principal Investigator Email
Sylvie.Rottey@ugent.be
Contact Person Name
Sylvie Rottey
Contact Person Email
Sylvie.Rottey@ugent.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Urology
Principal Investigator Name
Emmanuel Seront
Principal Investigator Email
emmanuel.Seront@saintluc.uclouvain.be
Contact Person Name
Emmanuel Seront
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Oncology
Principal Investigator Name
Sofie Demasure
Principal Investigator Email
sofie.demasure@azgroeninge.be
Contact Person Name
Sofie Demasure
Contact Person Email
sofie.demasure@azgroeninge.be

Denmark

Earliest CTIS Part Ii Submission Date
31-03-2025
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
267
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Lillebaelt Hospital
Department Name
Onkologisk Afdeling
Principal Investigator Name
Louise Raunkilde Larsen
Principal Investigator Email
louise.raunkilde.Larsen@rsyd.dk
Contact Person Name
Louise Raunkilde Larsen
Site Name
Rigshospitalet
Department Name
Dept Oncology, Phase I Unit
Principal Investigator Name
Jakob Lauritsen
Principal Investigator Email
jakob.lauritsen@regionh.dk
Contact Person Name
Jakob Lauritsen
Contact Person Email
jakob.lauritsen@regionh.dk
Site Name
Region Midtjylland
Department Name
Department of Oncology
Principal Investigator Name
Simon Buus
Principal Investigator Email
simon.buus@auh.rm.dk
Contact Person Name
Simon Buus
Contact Person Email
simon.buus@auh.rm.dk

France

Earliest CTIS Part Ii Submission Date
14-02-2025
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
343
Number Of Sites
19
Number Of Participants
75

Sites

Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie médicale
Principal Investigator Name
Emmanuelle BOMPAS
Principal Investigator Email
emmanuelle.bompas@ico.unicancer.fr
Contact Person Name
Emmanuelle BOMPAS
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Oncologie médicale
Principal Investigator Name
Benjamin AUBERGER
Principal Investigator Email
benjamin.auberger@chu-brest.fr
Contact Person Name
Benjamin AUBERGER
Contact Person Email
benjamin.auberger@chu-brest.fr
Site Name
Institut Paoli Calmettes
Department Name
Oncologie médicale
Principal Investigator Name
Gwenaelle GRAVIS
Principal Investigator Email
gravisg@ipc.unicancer.fr
Contact Person Name
Gwenaelle GRAVIS
Contact Person Email
gravisg@ipc.unicancer.fr
Site Name
Hopital Saint Louis
Department Name
Oncologie médicale
Principal Investigator Name
Clément DUMONT
Principal Investigator Email
clement.dumont@aphp.fr
Contact Person Name
Clément DUMONT
Contact Person Email
clement.dumont@aphp.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Oncologie médicale
Principal Investigator Name
Mathieu LARAMAS
Principal Investigator Email
mlaramas@chu-grenoble.fr
Contact Person Name
Mathieu LARAMAS
Contact Person Email
mlaramas@chu-grenoble.fr
Site Name
Centre Antoine Lacassagne
Department Name
Oncologie médicale
Principal Investigator Name
Delphine BORCHIELLINI
Principal Investigator Email
delphine.borchiellini@nice.unicancer.fr
Contact Person Name
Delphine BORCHIELLINI
Site Name
Oncopole Claudius Regaud
Department Name
Oncologie médicale
Principal Investigator Name
Loïc MOUREY
Principal Investigator Email
mourey.loic@iuct-oncopole.fr
Contact Person Name
Loïc MOUREY
Contact Person Email
mourey.loic@iuct-oncopole.fr
Site Name
Centre Oscar Lambret
Department Name
Oncologie médicale
Principal Investigator Name
Karim FIZAZI
Principal Investigator Email
k-fizazi@o-lambret.fr
Contact Person Name
Karim FIZAZI
Contact Person Email
k-fizazi@o-lambret.fr
Site Name
Centre Francois Baclesse
Department Name
Oncologie médicale
Principal Investigator Name
Florence JOLY Lobbedez
Principal Investigator Email
f.joly@baclesse.unicancer.fr
Contact Person Name
Florence JOLY Lobbedez
Contact Person Email
f.joly@baclesse.unicancer.fr
Site Name
Institut Gustave Roussy
Department Name
Oncologie médicale
Principal Investigator Name
Ronan FLIPPOT
Principal Investigator Email
ronan.flippot@gustaveroussy.fr
Contact Person Name
Ronan FLIPPOT
Contact Person Email
ronan.flippot@gustaveroussy.fr
Site Name
Institut Bergonie
Department Name
Oncologie médicale
Principal Investigator Name
Guilhem ROUBAUD
Principal Investigator Email
g.roubaud@bordeaux.unicancer.fr
Contact Person Name
Guilhem ROUBAUD
Site Name
Direction Centrale Du Service De Sante Des Armees
Department Name
94160
Principal Investigator Name
Hugo PICCHI
Principal Investigator Email
picchi.hugo90@gmail.com
Contact Person Name
Hugo PICCHI
Contact Person Email
picchi.hugo90@gmail.com
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Oncologie médicale
Principal Investigator Name
Marine GROSS-GOUPIL
Principal Investigator Email
marine.gross-goupil@chu-bordeaux.fr
Contact Person Name
Marine GROSS-GOUPIL
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Oncologie médicale
Principal Investigator Name
Philippe BARTHELEMY
Principal Investigator Email
p.barthelemy@icans.eu
Contact Person Name
Philippe BARTHELEMY
Contact Person Email
p.barthelemy@icans.eu
Site Name
Hospital Foch
Department Name
Oncologie médicale
Principal Investigator Name
Raffaele RATTA
Principal Investigator Email
r.ratta@hopital-foch.com
Contact Person Name
Raffaele RATTA
Contact Person Email
r.ratta@hopital-foch.com
Site Name
Clinique Victor Hugo
Department Name
Oncologie médicale
Principal Investigator Name
Ossama DIDAS
Principal Investigator Email
essaisdidas@ilcgroupe.fr
Contact Person Name
Ossama DIDAS
Contact Person Email
essaisdidas@ilcgroupe.fr
Site Name
Centre Jean Perrin
Department Name
Oncologie médicale
Principal Investigator Name
Hakim MAHAMMEDI
Principal Investigator Email
hakim.mahammedi@clermont.unicancer.fr
Contact Person Name
Hakim MAHAMMEDI
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncologie médicale
Principal Investigator Name
Stéphane OUDARD
Principal Investigator Email
stephane.oudard@aphp.fr
Contact Person Name
Stéphane OUDARD
Contact Person Email
stephane.oudard@aphp.fr
Site Name
Centre Leon Berard
Department Name
Oncologie médicale-Urologie
Principal Investigator Name
Aude FLECHON
Principal Investigator Email
aude.flechon@lyon.unicancer.fr
Contact Person Name
Aude FLECHON
Contact Person Email
aude.flechon@lyon.unicancer.fr

Germany

Earliest CTIS Part Ii Submission Date
11-03-2025
Latest Decision Or Authorization Date
02-01-2026
Processing Time Days
297
Number Of Sites
11
Number Of Participants
37

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Onkologisches Zentrum
Principal Investigator Name
Gunhild von Amsberg
Principal Investigator Email
g.von-amsberg@uke.de
Contact Person Name
Gunhild von Amsberg
Contact Person Email
g.von-amsberg@uke.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Urologische Klinik und Poliklinik
Principal Investigator Name
Margitta Retz
Principal Investigator Email
margitta.retz@tum.de
Contact Person Name
Margitta Retz
Contact Person Email
margitta.retz@tum.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Nationales Centrum fuer Tumorerkrankungen
Principal Investigator Name
Stefanie Zschaebitz
Principal Investigator Email
Stefanie.Zschaebitz@med.uni-heidelberg.de
Contact Person Name
Stefanie Zschaebitz
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Urologie Campus Lübeck
Principal Investigator Name
Axel Merseburger
Principal Investigator Email
axel.merseburger@uksh.de
Contact Person Name
Axel Merseburger
Contact Person Email
axel.merseburger@uksh.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin II
Principal Investigator Name
Marc-Oliver Grimm
Principal Investigator Email
marc-oliver.grimm@med.uni-jena.de
Contact Person Name
Marc-Oliver Grimm
Site Name
Universitaet Muenster
Department Name
Klinik fuer Urologie
Principal Investigator Name
Katrin Schlack
Principal Investigator Email
katrin.schlack@ukmuenster.de
Contact Person Name
Katrin Schlack
Contact Person Email
katrin.schlack@ukmuenster.de
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Urologie
Principal Investigator Name
Christian Thomas
Principal Investigator Email
Christian.Thomas@uniklinikum-dresden.de
Contact Person Name
Christian Thomas
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Urologische Klinik
Principal Investigator Name
Maria de Santis
Principal Investigator Email
Maria.de-Santis@charite.de
Contact Person Name
Maria de Santis
Contact Person Email
Maria.de-Santis@charite.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Barbara Deschler-Baier
Principal Investigator Email
Deschler_B@ukw.de
Contact Person Name
Barbara Deschler-Baier
Contact Person Email
Deschler_B@ukw.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Urologie Gebäude 13 71
Principal Investigator Name
Guenter Niegisch
Principal Investigator Email
guenter.niegisch@med.uni-duesseldorf.de
Contact Person Name
Guenter Niegisch
Site Name
Universitaetsklinikum Essen AöR
Department Name
Innere Klinik Tumorforschung
Principal Investigator Name
Viktor Gruenwald
Principal Investigator Email
Viktor.Gruenwald@uk-essen.de
Contact Person Name
Viktor Gruenwald
Contact Person Email
Viktor.Gruenwald@uk-essen.de

Greece

Earliest CTIS Part Ii Submission Date
12-12-2024
Latest Decision Or Authorization Date
24-12-2025
Processing Time Days
377
Number Of Sites
10
Number Of Participants
28

Sites

Site Name
University General Hospital Of Heraklion
Department Name
Medical Oncology Department
Principal Investigator Name
Dimitrios Mavroudis
Principal Investigator Email
medoncsec@med.uoc.gr
Contact Person Name
Dimitrios Mavroudis
Contact Person Email
medoncsec@med.uoc.gr
Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Principal Investigator Name
Marinos Tsiatas
Principal Investigator Email
tsiatas@hotmail.com
Contact Person Name
Marinos Tsiatas
Contact Person Email
tsiatas@hotmail.com
Site Name
Alexandra Hospital
Department Name
Oncology Department, Department of Clinical Therapeutics
Principal Investigator Name
Michalis Liontos
Principal Investigator Email
mliontos@gmail.com
Contact Person Name
Michalis Liontos
Contact Person Email
mliontos@gmail.com
Site Name
General University Hospital Of Patras
Department Name
Division of Oncology
Principal Investigator Name
Angelos Koutras
Principal Investigator Email
angkoulr@upatras.gr
Contact Person Name
Angelos Koutras
Contact Person Email
angkoulr@upatras.gr
Site Name
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Department Name
Oncologic Clinical Trials and Research Clinic
Principal Investigator Name
Evangelos Bournakis
Principal Investigator Email
vagimith@yahoo.com
Contact Person Name
Evangelos Bournakis
Contact Person Email
vagimith@yahoo.com
Site Name
Metropolitan Hospital
Department Name
2nd Oncology Department
Principal Investigator Name
Christos Christodoulou
Principal Investigator Email
c.christodoulou_trials@yahoo.gr
Contact Person Name
Christos Christodoulou
Site Name
Athens Medical Center S.A. (Thessaloniki)
Department Name
Oncology Department
Principal Investigator Name
Sofia Baka
Principal Investigator Email
bakasofia@hotmail.com
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
Athens Medical Center S.A. (Thessaloniki - Pylea)
Department Name
3rd Department of Oncology
Principal Investigator Name
Loukas Kontovinis
Principal Investigator Email
L.kontovinis@oncomedicare.com
Contact Person Name
Loukas Kontovinis
Contact Person Email
L.kontovinis@oncomedicare.com
Site Name
Metaxa Cancer Center Hospital Of Piraeus
Department Name
Medical Oncology Department
Principal Investigator Name
Evangelos Lianos
Principal Investigator Email
lianos@metaxa-hospital.gov.gr
Contact Person Name
Evangelos Lianos
Contact Person Email
lianos@metaxa-hospital.gov.gr
Site Name
Athens Medical Center S.A. (Thessaloniki - additional site)
Department Name
4th Department of Medical Oncology
Principal Investigator Name
Ippokratis Korantzis
Principal Investigator Email
ippokratis.korantzis@gmail.com
Contact Person Name
Ippokratis Korantzis
Contact Person Email
ippokratis.korantzis@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
28-01-2025
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
329
Number Of Sites
7
Number Of Participants
64

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità Clinica Oncologia Medica
Principal Investigator Name
Andrea Necchi
Principal Investigator Email
necchi.andrea@hsr.it
Contact Person Name
Andrea Necchi
Contact Person Email
necchi.andrea@hsr.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica 1
Principal Investigator Name
Elena Verzoni
Principal Investigator Email
elena.verzoni@istitutotumori.mi.it
Contact Person Name
Elena Verzoni
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Oncologia Medica 1
Principal Investigator Name
Giuseppe Fornarini
Principal Investigator Email
giuseppe.fornarini@hsanmartino.it
Contact Person Name
Giuseppe Fornarini
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
Oncologia Medica e Terapia Biomolecolare
Principal Investigator Name
Vincenza Conteduca
Principal Investigator Email
vincenza.conteduca@unifg.it
Contact Person Name
Vincenza Conteduca
Contact Person Email
vincenza.conteduca@unifg.it
Site Name
Azienda Sanitaria Locale Della Provincia Di Lecce
Department Name
Oncologia Medica
Principal Investigator Name
Vincenzo Emanuele Chiuri
Principal Investigator Email
vincenzoemanuele.chiuri@asl.lecce.it
Contact Person Name
Vincenzo Emanuele Chiuri
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Oncologia
Principal Investigator Name
Consuelo Buttigliero
Principal Investigator Email
consuelo.buttigliero@unito.it
Contact Person Name
Consuelo Buttigliero
Contact Person Email
consuelo.buttigliero@unito.it
Site Name
Azienda Provinciale Per I Servizi Sanitari
Department Name
Oncologia Medica
Principal Investigator Name
Orazio Caffo
Principal Investigator Email
ospedale.trento@pec.apss.tn.it
Contact Person Name
Orazio Caffo
Contact Person Email
ospedale.trento@pec.apss.tn.it

Netherlands

Earliest CTIS Part Ii Submission Date
04-03-2025
Latest Decision Or Authorization Date
24-12-2025
Processing Time Days
295
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Reinier de Graaf Groep
Department Name
Oncology
Principal Investigator Name
Addy van de Luijtgaarden
Principal Investigator Email
A.vandeLuijtgaarden@rdgg.nl
Contact Person Name
Addy van de Luijtgaarden
Contact Person Email
A.vandeLuijtgaarden@rdgg.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Medical Oncology
Principal Investigator Name
Michel van Kruchten
Principal Investigator Email
m.van.kruchten@umcg.nl
Contact Person Name
Michel van Kruchten
Contact Person Email
m.van.kruchten@umcg.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Medical Oncology
Principal Investigator Name
Koen van der Mijn
Principal Investigator Email
k.vd.mijn@nki.nl
Contact Person Name
Koen van der Mijn
Contact Person Email
k.vd.mijn@nki.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Medical Oncology
Principal Investigator Name
Niven Mehra
Principal Investigator Email
Niven.Mehra@radboudumc.nl
Contact Person Name
Niven Mehra
Contact Person Email
Niven.Mehra@radboudumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Medical Oncology
Principal Investigator Name
Nick Beije
Principal Investigator Email
n.beije@erasmusmc.nl
Contact Person Name
Nick Beije
Contact Person Email
n.beije@erasmusmc.nl
Site Name
Universitair Medisch Centrum Groningen (additional)
Department Name
Medical Oncology

Poland

Earliest CTIS Part Ii Submission Date
12-03-2025
Latest Decision Or Authorization Date
04-01-2026
Processing Time Days
298
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Oncology
Principal Investigator Name
Katarzyna Sosinska-Mielcarek
Principal Investigator Email
obkwf@uck.gda.pl
Contact Person Name
Katarzyna Sosinska-Mielcarek
Contact Person Email
obkwf@uck.gda.pl
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Urology
Principal Investigator Name
Dolowy Lukasz
Principal Investigator Email
onkocwbk@dcopih.pl
Contact Person Name
Dolowy Lukasz
Contact Person Email
onkocwbk@dcopih.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oncology
Principal Investigator Name
Piotr Wysocki
Principal Investigator Email
klinikaonkologii@su.krakow.pl
Contact Person Name
Piotr Wysocki
Contact Person Email
klinikaonkologii@su.krakow.pl

Spain

Earliest CTIS Part Ii Submission Date
01-04-2025
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
283
Number Of Sites
11
Number Of Participants
32

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio de Oncologia Medica
Principal Investigator Name
Begoña Perez Valderrama
Contact Person Name
Begoña Perez Valderrama
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Servicio de Oncologia Medica
Principal Investigator Name
David Lorente Estelles
Principal Investigator Email
dlorenteestelles@seom.org
Contact Person Name
David Lorente Estelles
Contact Person Email
dlorenteestelles@seom.org
Site Name
Institut Catala D'oncologia
Department Name
Servicio de Oncologia Medica
Principal Investigator Name
Josep Maria Piulats Rodriguez
Principal Investigator Email
jmpiulats@iconcologia.net
Contact Person Name
Josep Maria Piulats Rodriguez
Contact Person Email
jmpiulats@iconcologia.net
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Servicio de Oncologia
Principal Investigator Name
Jose Pablo Maroto
Principal Investigator Email
jmaroto@santpau.es
Contact Person Name
Jose Pablo Maroto
Contact Person Email
jmaroto@santpau.es
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Servicio de Oncologia Medica
Principal Investigator Name
Jose Luis Perez Gracia
Principal Investigator Email
jlgracia@unav.es
Contact Person Name
Jose Luis Perez Gracia
Contact Person Email
jlgracia@unav.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Oncologia
Principal Investigator Name
Joan Carles Galceran
Principal Investigator Email
jcarles@vhio.net
Contact Person Name
Joan Carles Galceran
Contact Person Email
jcarles@vhio.net
Site Name
Hospital Clinico San Carlos
Department Name
Servicio de Oncologia Medica
Principal Investigator Name
Javier Puente Vazquez
Principal Investigator Email
javierpuente.hcsc@gmail.com
Contact Person Name
Javier Puente Vazquez
Contact Person Email
javierpuente.hcsc@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Servicio de Oncologia Medica
Principal Investigator Name
Alvaro Montesa Pino
Principal Investigator Email
montesaensayos@gmail.com
Contact Person Name
Alvaro Montesa Pino
Contact Person Email
montesaensayos@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de Oncologia Medica
Principal Investigator Name
Daniel Castellano
Principal Investigator Email
cdanicas@hotmail.com
Contact Person Name
Daniel Castellano
Contact Person Email
cdanicas@hotmail.com
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Servicio de Oncologia Medica
Principal Investigator Name
Jose Luis Perez Gracia
Principal Investigator Email
jlgracia@unav.es
Contact Person Name
Jose Luis Perez Gracia
Contact Person Email
jlgracia@unav.es
Site Name
Hospital Clinic De Barcelona
Department Name
Servicio de Oncologia Medica
Principal Investigator Name
Begoña Mellado González
Principal Investigator Email
BMELLADO@clinic.cat
Contact Person Name
Begoña Mellado González
Contact Person Email
BMELLADO@clinic.cat

Sweden

Earliest CTIS Part Ii Submission Date
13-03-2025
Latest Decision Or Authorization Date
07-01-2026
Processing Time Days
300
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Region Vaesterbotten
Department Name
Cancercentrum
Principal Investigator Name
Camilla Thellenberg Karlsson
Principal Investigator Email
camilla.thellenberg@umu.se
Contact Person Name
Camilla Thellenberg Karlsson
Contact Person Email
camilla.thellenberg@umu.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Onkologiska kliniken
Principal Investigator Name
Jon Kindblom
Principal Investigator Email
jon.kindblom@vgregion.se
Contact Person Name
Jon Kindblom
Contact Person Email
jon.kindblom@vgregion.se
Site Name
Karolinska University Hospital
Department Name
Solna Onkologiska kliniken
Principal Investigator Name
Enrique Castellanos
Principal Investigator Email
enrique.castellanos@sll.se
Contact Person Name
Enrique Castellanos
Contact Person Email
enrique.castellanos@sll.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Onkologiska kliniken/Department of Oncology
Principal Investigator Name
Olof Stahl
Principal Investigator Email
olof.stahl@skane.se
Contact Person Name
Olof Stahl
Contact Person Email
olof.stahl@skane.se

Sponsor

Primary sponsor

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

Contract research organisations

Name
Excelya Greece CRO Single Member S.A.
Responsibilities
Site Start-up, Monitoring & close-out activities; Submission activities
Name
Iqvia Rds Inc.
Responsibilities
Site Start-up, Monitoring & close-out activities
Name
Omnitrace Corp.
Responsibilities
Recruitment Retention

Third parties

  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long Term Storage; code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"code: 1; Site Start-up, Monitoring & close-out activities","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"ePRO vendor & eDiary (code: 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Biologics Development Services LLC","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code: 4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging Vendor (code: 15)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"PK samples (code: 15); code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"Site Start-up, Monitoring & close-out activities; Submission activities (code: 1; code: 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"Recruitment Retention (code: 15)","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
AMG 509
Active Substance
XALURITAMIG
Modality
Bispecific antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS

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