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
11-07-2025
First CTIS Authorization Date
03-11-2025

Trial design

Randomised, open-label, investigator's choice: docetaxel, cabazitaxel, or abiraterone (doses/schedules not specified)-controlled Phase III trial in Austria, Belgium, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigator's choice: docetaxel, cabazitaxel, or abiraterone (doses/schedules not specified)
Target Sample Size
455

Eligibility

Recruits 455 Vulnerable population not selected. Participants must be ≥18 years (or legal adult in the country) and must provide informed consent prior to any study-specific activities. No provisions for assent/minor consent are described in the provided criteria; no vulnerable subpopulations (eg, children) are selected..

Vulnerable Population
Vulnerable population not selected. Participants must be ≥18 years (or legal adult in the country) and must provide informed consent prior to any study-specific activities. No provisions for assent/minor consent are described in the provided criteria; no vulnerable subpopulations (eg, children) are selected.

Inclusion criteria

  • {"criterion_text":"- Participant has provided informed consent before initiation of any study-specific activities/procedures"}
  • {"criterion_text":"- Adequate organ function"}
  • {"criterion_text":"- Age greater than or equal to 18 years (or greater than or equal to legal age within the country if it is older than 18 years) at the time of signing the informed consent"}
  • {"criterion_text":"- Participant must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate"}
  • {"criterion_text":"- mCRPC with greater than or equal to 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days before enrollment"}
  • {"criterion_text":"- Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria"}
  • {"criterion_text":"- Participants must have had prior orchiectomy and/or ongoing androgren-deprivation therapy (ADT) and a castrate level of serum testosterone (less than 50 ng/dL or less than 1.7 nmol/L)"}
  • {"criterion_text":"- Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required"}
  • {"criterion_text":"- Participants intended to receive cabazitaxel must have previously received less than or equal to 6 cycles of docetaxel in the mHSPC setting"}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1"}

Exclusion criteria

  • {"criterion_text":"- Participants with a history of central nervous system (CNS) metastases"}
  • {"criterion_text":"- Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy"}
  • {"criterion_text":"- Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment"}
  • {"criterion_text":"- Unresolved toxicities from prior antitumor therapy not having resolved to CTCAE version 5.0 grade 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"}
  • {"criterion_text":"- Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy"}
  • {"criterion_text":"- Prior disease progression on or intolerance to abiraterone"}
  • {"criterion_text":"- Prior treatment with any chemotherapy regimen in the mCRPC setting and/or greater than 6 cycles of docetaxel treatment in the mHSPC setting"}
  • {"criterion_text":"- Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment, not including androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotropin releasing hormone [LHRH/GnRH] analogue [agonist/antagonist])"}
  • {"criterion_text":"- Prior Prostate-Specific Membrane Antigen (PSMA) radioligand therapy (RLT) within 3 months of first dose of study treatment. Participants who received less than 2 cycles of PSMA RLT within 6 weeks of first dose of study treatment are also excluded"}
  • {"criterion_text":"- Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment"}
  • {"criterion_text":"- Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"To compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone)"}

Secondary endpoints

  • {"endpoint_text":"- rPFS per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), per investigator assessment","definition_or_measurement_approach":"rPFS per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST 1.1, per investigator assessment"}
  • {"endpoint_text":"- Objective response per modified RECIST 1.1, per investigator assessment","definition_or_measurement_approach":"Objective response per modified RECIST 1.1, per investigator assessment"}
  • {"endpoint_text":"- Duration of Response (DOR) per modified RECIST 1.1, per investigator assessment","definition_or_measurement_approach":"Duration of Response (DOR) per modified RECIST 1.1, per investigator assessment"}
  • {"endpoint_text":"- Disease Control per modified RECIST 1.1, per investigator assessment","definition_or_measurement_approach":"Disease Control per modified RECIST 1.1, per investigator assessment"}
  • {"endpoint_text":"- Progression-free survival (PFS) 2, per investigator assessment","definition_or_measurement_approach":"Progression-free survival (PFS) 2, per investigator assessment"}
  • {"endpoint_text":"- Time to Response (TTR), per modified RECIST 1.1, per investigator assessment","definition_or_measurement_approach":"Time to Response (TTR), per modified RECIST 1.1, per investigator assessment"}
  • {"endpoint_text":"- Time to first subsequent therapy","definition_or_measurement_approach":"Time to first subsequent therapy as recorded in study treatment records"}
  • {"endpoint_text":"- Time to symptomatic skeletal events (SSE)","definition_or_measurement_approach":"Time to symptomatic skeletal events (SSE) as defined in study methods"}
  • {"endpoint_text":"- Treatment-emergent adverse events, treatment-emergent serious adverse events, and fatal adverse events","definition_or_measurement_approach":"Incidence and characterization of treatment-emergent AEs, SAEs and fatal AEs collected during study"}
  • {"endpoint_text":"- Time to worsening as measured by: - BPI-SF Worst pain score - BPI-SF Pain intensity scale - BPI-SF Pain interference scale - FACT-P Total score","definition_or_measurement_approach":"Patient-reported measures (BPI-SF, FACT-P) assessed at scheduled visits to determine time to worsening"}
  • {"endpoint_text":"- Time to improvement as measured by BPI-SF Worst pain score in participants with moderate/severe pain at baseline","definition_or_measurement_approach":"Time to improvement using BPI-SF worst pain score in participants with moderate/severe baseline pain"}
  • {"endpoint_text":"- Time to improvement after worsening as measured by BPI-SF Pain intensity scale score and BPI-SF Pain interference scale score","definition_or_measurement_approach":"Time to improvement after worsening assessed using BPI-SF pain intensity and interference scales"}
  • {"endpoint_text":"- Patient-reported outcomes summary scores over time at each assessment as measured by: - Selected questions on symptomatic adverse events from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) item library - The GP5 question on overall bother of side effects from the FACT-P questionnaire","definition_or_measurement_approach":"Summary patient-reported outcomes over time using PRO-CTCAE items and FACT-P GP5 question"}
  • {"endpoint_text":"- Prostate-specific antigen (PSA) 50 and PSA 90 responses","definition_or_measurement_approach":"PSA50 and PSA90 responses measured using central/local laboratory PSA values"}
  • {"endpoint_text":"- Time to PSA 50 and PSA 90 responses","definition_or_measurement_approach":"Time from randomization to achievement of PSA50 and PSA90 responses"}
  • {"endpoint_text":"- Duration of PSA 50 and PSA 90 response","definition_or_measurement_approach":"Duration from first PSA50/PSA90 response to documented PSA progression"}
  • {"endpoint_text":"- Time to PSA progression","definition_or_measurement_approach":"Time from randomization to PSA-defined progression"}
  • {"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 (t1/2)","definition_or_measurement_approach":"Standard PK sampling (intensive and sparse) to derive Cmax, Tmax, Cmin, AUC, accumulation and t1/2 for xaluritamig"}
  • {"endpoint_text":"- Abiraterone PK concentrations at end of dosing interval","definition_or_measurement_approach":"Measurement of abiraterone concentrations at the end of dosing interval"}
  • {"endpoint_text":"- Incidence of anti-xaluritamig antibody formation","definition_or_measurement_approach":"Immunogenicity assessments to detect anti-xaluritamig antibodies"}
  • {"endpoint_text":"- Change from baseline over time at each assessment as measured by: - BPI-SF Worst pain score - BPI-SF Pain intensity scale - BPI-SF Pain interference scale - FACT-P Total score and subscale scores - EQ-5D-5L Utility score - Change from baseline in the EQ-5D-5L Visual Analogue Scale (VAS)","definition_or_measurement_approach":"Change from baseline using listed patient-reported outcome instruments at scheduled assessments"}

Recruitment

Planned Sample Size
455
Recruitment Window Months
81
Consent Approach
Participants (≥18 years or legal adult) must provide informed consent prior to any study-specific activities. Informed consent forms and subject information are provided; patient-facing documents and ICFs are available in multiple languages (examples in documents: EN, DE, FR, NL, ES, GR, IT, PT). Pregnancy-specific information/ICFs and treatment-beyond-progression ICFs are provided where applicable. No assent procedures for minors are described (minors are excluded).

Geography

Total Number Of Sites
69
Total Number Of Participants
455

Austria

Earliest CTIS Part Ii Submission Date
23-07-2025
Latest Decision Or Authorization Date
03-11-2025
Processing Time Days
103
Number Of Sites
4
Number Of Participants
16

Sites

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
Ordensklinikum Linz GmbH
Department Name
Department of Urology and Andrology
Principal Investigator Name
David Kiesl
Principal Investigator Email
David.Kiesl@Ordensklinikum.at
Contact Person Name
David Kiesl
Contact Person Email
David.Kiesl@Ordensklinikum.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
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

Belgium

Earliest CTIS Part Ii Submission Date
01-10-2025
Latest Decision Or Authorization Date
03-11-2025
Processing Time Days
33
Number Of Sites
5
Number Of Participants
24

Sites

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
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Medische Oncologie
Principal Investigator Name
Lionel D'Hondt
Principal Investigator Email
lionel.dhondt@chuuclnamur.uclouvain.be
Contact Person Name
Lionel D'Hondt
Site Name
Universitair Ziekenhuis Gent
Department Name
Medische Oncologie
Principal Investigator Name
Sylvie Rottey
Principal Investigator Email
Sylvie.Rottey@uzgent.be
Contact Person Name
Sylvie Rottey
Contact Person Email
Sylvie.Rottey@uzgent.be
Site Name
UZ Leuven
Department Name
General Medical Oncology
Principal Investigator Name
Herlinde Dumez
Principal Investigator Email
Herlinde.Dumez@uzleuven.be
Contact Person Name
Herlinde Dumez
Contact Person Email
Herlinde.Dumez@uzleuven.be
Site Name
Institut Jules Bordet
Department Name
Medische Oncologie
Principal Investigator Name
Nieves Martinez Chanza
Principal Investigator Email
n.martinezchanza@hubruxelles.be
Contact Person Name
Nieves Martinez Chanza

Germany

Earliest CTIS Part Ii Submission Date
29-09-2025
Latest Decision Or Authorization Date
06-11-2025
Processing Time Days
38
Number Of Sites
11
Number Of Participants
40

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
Universitaetsklinikum Erlangen AöR
Department Name
Urologische und Kinderurologische Klinik
Principal Investigator Name
Peter Goebell
Principal Investigator Email
peter.goebell@uk-erlangen.de
Contact Person Name
Peter Goebell
Contact Person Email
peter.goebell@uk-erlangen.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Campus Mitte Klinik fuer Urologie
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
Comprehensive Cancer Center – Mainfranken (CCCMF)
Principal Investigator Name
Anna Katharina Seitz
Principal Investigator Email
seitz_a3@ukw.de
Contact Person Name
Anna Katharina Seitz
Contact Person Email
seitz_a3@ukw.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Campus Kiel / Klinik für Urologie
Principal Investigator Name
Philipp Nuhn
Principal Investigator Email
Direktion.urologie.kiel@uksh.de
Contact Person Name
Philipp Nuhn
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Nationales Centrum für Tumorerkrankungen
Principal Investigator Name
Stefanie Zschaebitz
Principal Investigator Email
Stefanie.Zschaebitz@med.uni-heidelberg.de
Contact Person Name
Stefanie Zschaebitz
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Hämatologie und Onkologie
Principal Investigator Name
Moritz Kleemiss
Principal Investigator Email
studienzentrale-szb@ukbonn.de
Contact Person Name
Moritz Kleemiss
Contact Person Email
studienzentrale-szb@ukbonn.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Innere Klinik - Tumorforschung
Principal Investigator Name
Christopher Darr
Principal Investigator Email
Christopher.Darr@uk-essen.de
Contact Person Name
Christopher Darr
Contact Person Email
Christopher.Darr@uk-essen.de
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Urologie
Principal Investigator Name
Christian Thomas
Contact Person Name
Christian Thomas
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik und Poliklinik fuer Urologie
Principal Investigator Name
Marc-Oliver Grimm
Principal Investigator Email
marc-oliver.grimm@med.uni-jena.de
Contact Person Name
Marc-Oliver Grimm
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Urologie und Kinderurologie , Urologische Studienzentrale
Principal Investigator Name
Friedemann Zengerling
Principal Investigator Email
Friedemann.Zengerling@uniklinik-ulm.de
Contact Person Name
Friedemann Zengerling

Greece

Earliest CTIS Part Ii Submission Date
23-07-2025
Latest Decision Or Authorization Date
04-11-2025
Processing Time Days
104
Number Of Sites
10
Number Of Participants
36

Sites

Site Name
General Oncological Hospital Of Kifissia Agioi Anargyroi
Department Name
Department of Medical Oncology
Principal Investigator Name
Despoina Nasi
Principal Investigator Email
docnasi1@hotmail.gr
Contact Person Name
Despoina Nasi
Contact Person Email
docnasi1@hotmail.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
University General Hospital Attikon
Department Name
2nd Propaedeutic Department of Pathology
Principal Investigator Name
Aristotelis Bamias
Principal Investigator Email
abamias@med.uoa.gr
Contact Person Name
Aristotelis Bamias
Contact Person Email
abamias@med.uoa.gr
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
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
University General Hospital Of Alexandroupoli
Department Name
Oncology Department
Principal Investigator Name
Dimitrios Matthaios
Principal Investigator Email
dmatthai@med.duth.gr
Contact Person Name
Dimitrios Matthaios
Contact Person Email
dmatthai@med.duth.gr
Site Name
Athens Medical Center S.A. (Thessaloniki site)
Department Name
3rd Department of Oncology
Principal Investigator Name
Loukas Kontovinis
Principal Investigator Email
i.kontovinis@oncomedicare.com
Contact Person Name
Loukas Kontovinis
Contact Person Email
i.kontovinis@oncomedicare.com
Site Name
Athens Medical Center S.A. (Pylea site)
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. (Pylea - 4th Department?)
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
Site Name
Henry Dunant Hospital Center
Department Name
4th Oncology Department
Principal Investigator Name
Maria Lykka
Principal Investigator Email
marialykka@gmail.com
Contact Person Name
Maria Lykka
Contact Person Email
marialykka@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
01-10-2025
Latest Decision Or Authorization Date
03-11-2025
Processing Time Days
33
Number Of Sites
8
Number Of Participants
40

Sites

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
Humanitas Mirasole S.p.A.
Department Name
Unita Operativa di Oncologia Medica ed Ematologia
Principal Investigator Name
Paolo Andrea Zucali
Principal Investigator Email
paolo.zucali@cancercenter.humanitas.it
Contact Person Name
Paolo Andrea Zucali
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
Azienda Ospedaliero Universitaria Di Modena
Department Name
Oncologia
Principal Investigator Name
Roberto Sabbatini
Principal Investigator Email
sabbatini@unimore.it
Contact Person Name
Roberto Sabbatini
Contact Person Email
sabbatini@unimore.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
Azienda Provinciale Per I Servizi Sanitari
Department Name
Oncologia Medica
Principal Investigator Name
Orazio Caffo
Principal Investigator Email
orazio.caffo@apss.tn.it
Contact Person Name
Orazio Caffo
Contact Person Email
orazio.caffo@apss.tn.it
Site Name
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
Department Name
Oncologia
Principal Investigator Name
Davide Pastorelli
Principal Investigator Email
davide.pastorelli@ulssfeltre.veneto.it
Contact Person Name
Davide Pastorelli
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

Portugal

Earliest CTIS Part Ii Submission Date
02-10-2025
Latest Decision Or Authorization Date
06-11-2025
Processing Time Days
35
Number Of Sites
5
Number Of Participants
22

Sites

Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Serviço de Oncologia Médica
Principal Investigator Name
Sara Meireles
Principal Investigator Email
sara.meireles@ulssjoao.min-saude.pt
Contact Person Name
Sara Meireles
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Serviço de Onco-Hematologia
Principal Investigator Name
Filipa Carneiro
Principal Investigator Email
ana.carneiro@ipoporto.min-saude.pt
Contact Person Name
Filipa Carneiro
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Serviço de Oncologia Médica
Principal Investigator Name
Andreia Capela
Principal Investigator Email
andreia.capela@ulsge.min-saude.pt
Contact Person Name
Andreia Capela
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Serviço de Oncologia Médica
Principal Investigator Name
Raquel Lopes Bras
Principal Investigator Email
raquel.bras@ulssm.min-saude.pt
Contact Person Name
Raquel Lopes Bras
Contact Person Email
raquel.bras@ulssm.min-saude.pt
Site Name
Hospital Da Luz S.A.
Department Name
Serviço de Oncologia
Principal Investigator Name
João Moreira Pinto
Principal Investigator Email
joao.pmoreira.pinto@hospitaldaluz.pt
Contact Person Name
João Moreira Pinto

Spain

Earliest CTIS Part Ii Submission Date
09-10-2025
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
29
Number Of Sites
13
Number Of Participants
52

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Marta García de Herreros Dunyac
Principal Investigator Email
garciadehe@clinic.cat
Contact Person Name
Marta García de Herreros Dunyac
Contact Person Email
garciadehe@clinic.cat
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Aurea Molina Díaz
Principal Investigator Email
aurea.molina.diaz@sergas.es
Contact Person Name
Aurea Molina Díaz
Contact Person Email
aurea.molina.diaz@sergas.es
Site Name
Hospital Universitario Lucus Augusti
Department Name
Servicio de Oncologia
Principal Investigator Name
Sergio Vazquez Estevez
Principal Investigator Email
sergio.vazquez.estevez@sergas.es
Contact Person Name
Sergio Vazquez Estevez
Site Name
Hospital Universitario Regional De Malaga
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 Clinico San Carlos
Department Name
Servicio de Oncologia Medica
Principal Investigator Name
Javier Puente Vazquez
Principal Investigator Email
javierpuente.hscs@gmail.com
Contact Person Name
Javier Puente Vazquez
Contact Person Email
javierpuente.hscs@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Servicio de Oncología
Principal Investigator Name
José Pablo Maroto Rey
Principal Investigator Email
jmaroto@santpau.es
Contact Person Name
José Pablo Maroto Rey
Contact Person Email
jmaroto@santpau.es
Site Name
Hospital De Jerez De La Frontera
Department Name
Servicio de Oncología
Principal Investigator Name
Ana Isabel Vacas Rama
Principal Investigator Email
anavrama@gmail.com
Contact Person Name
Ana Isabel Vacas Rama
Contact Person Email
anavrama@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de Oncologia
Principal Investigator Name
Daniel Ernesto Castellano Gauna
Principal Investigator Email
cdanicas@hotmail.com
Contact Person Name
Daniel Ernesto Castellano Gauna
Contact Person Email
cdanicas@hotmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Servicio de Oncología
Principal Investigator Name
Lucia Oliva Fernandez
Principal Investigator Email
luciaolifer3@gmail.com
Contact Person Name
Lucia Oliva Fernandez
Contact Person Email
luciaolifer3@gmail.com
Site Name
Clinica Universidad De Navarra
Department Name
Servicio de Oncología Médica
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 Oncología
Principal Investigator Name
Joaquín Mateo Valderrama
Principal Investigator Email
mfenor@vhio.net
Contact Person Name
Joaquín Mateo Valderrama
Contact Person Email
mfenor@vhio.net
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Aránzazu González del Alba
Principal Investigator Email
aranzazu.gonzalezalba@salud.madrid.org
Contact Person Name
Aránzazu González del Alba
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Servicio de Oncologia
Principal Investigator Name
Teresa Alonso Gordoa
Principal Investigator Email
talonso@oncologiahrc.com
Contact Person Name
Teresa Alonso Gordoa
Contact Person Email
talonso@oncologiahrc.com

Netherlands

Earliest CTIS Part Ii Submission Date
25-09-2025
Latest Decision Or Authorization Date
04-11-2025
Processing Time Days
40
Number Of Sites
1
Number Of Participants
5

Sites

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

France

Earliest CTIS Part Ii Submission Date
13-10-2025
Latest Decision Or Authorization Date
13-11-2025
Processing Time Days
31
Number Of Sites
12
Number Of Participants
60

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service Oncologie
Principal Investigator Name
Stephane Oudard
Principal Investigator Email
stephane.oudard@aphp.fr
Contact Person Name
Stephane Oudard
Contact Person Email
stephane.oudard@aphp.fr
Site Name
Centre Jean Perrin
Department Name
Oncologie médicale
Principal Investigator Name
Hakim Mahammedi
Principal Investigator Email
hakim.mahammedi@cjp.fr
Contact Person Name
Hakim Mahammedi
Contact Person Email
hakim.mahammedi@cjp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service d'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
Clinique Victor Hugo
Department Name
Oncologie Thérapeutique
Principal Investigator Name
Ossama Didas
Principal Investigator Email
essaisdidas@ilcgroupe.fr
Contact Person Name
Ossama Didas
Contact Person Email
essaisdidas@ilcgroupe.fr
Site Name
Hospital Foch
Department Name
Service Oncologie
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
Institut De Cancerologie De L Ouest
Department Name
Service Oncologie
Principal Investigator Name
Emmanuelle Bompas
Principal Investigator Email
emmanuelle.bompas@ico.unicancer.fr
Contact Person Name
Emmanuelle Bompas
Site Name
Oncopole Claudius Regaud
Department Name
Service Oncologie
Principal Investigator Name
Loic Mourey
Principal Investigator Email
mourey.loic@iuct-oncopole.fr
Contact Person Name
Loic Mourey
Contact Person Email
mourey.loic@iuct-oncopole.fr
Site Name
Centre Francois Baclesse
Department Name
Service de Radiotherapie et Oncologie Medicale
Principal Investigator Name
Florence Joly
Principal Investigator Email
f.joly@baclesse.unicancer.fr
Contact Person Name
Florence Joly
Contact Person Email
f.joly@baclesse.unicancer.fr
Site Name
Institut Gustave Roussy
Department Name
Departement de Medecine oncologique
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
Centre Antoine Lacassagne
Department Name
Service Oncologie medicale
Principal Investigator Name
Delphine Borchiellini
Principal Investigator Email
delphine.borchiellini@nice.unicancer.fr
Contact Person Name
Delphine Borchiellini
Site Name
Centre Leon Berard
Department Name
Oncologie medicale
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
Site Name
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Department Name
Service Oncologie
Principal Investigator Name
Carole Helissey
Principal Investigator Email
chelissey@ghpsj.fr
Contact Person Name
Carole Helissey
Contact Person Email
chelissey@ghpsj.fr

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 and close-out activities, submission activities
Name
Ppd Inc.

Third parties

  • {"country":"United States","full_name":"Biologics Development Services LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"ePRO and eDiary vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging vendor","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"Long-term sample storage","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"Site start-up, monitoring and close-out activities, submission activities","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long-term sample storage","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
AMG 509
Active Substance
XALURITAMIG
Modality
Bispecific antibody
Routes Of Administration
Intravenous
Route
INTRAVENOUS
Authorisation Status
Investigational
Investigational Product Name
ABIRATERONE ACETATE
Active Substance
ABIRATERONE ACETATE
Modality
Small molecule
Routes Of Administration
Oral
Route
ORAL
Authorisation Status
Authorised
Investigational Product Name
CABAZITAXEL
Active Substance
CABAZITAXEL
Modality
Small molecule
Routes Of Administration
Intravenous
Route
INTRAVENOUS
Authorisation Status
Authorised
Investigational Product Name
DOCETAXEL
Active Substance
DOCETAXEL
Modality
Small molecule
Routes Of Administration
Intravenous
Route
INTRAVENOUS
Authorisation Status
Authorised
Investigational Product Name
SYLVANT 400 mg powder for concentrate for solution for infusion
Active Substance
SILTUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
INTRAVENOUS
Authorisation Status
Authorised
Combination Treatment
Yes

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