Clinical trial • Phase I • Oncology
225Ac-PSMA-Trillium (BAY 3563254) for Metastatic castration-resistant prostate cancer (mCRPC)
Phase I trial of 225Ac-PSMA-Trillium (BAY 3563254) for Metastatic castration-resistant prostate cancer (mCRPC). open-label, none/not specified-controlled.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic castration-resistant prostate cancer (mCRPC)
- Trial Stage
- Phase I
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 30-11-2023
- First CTIS Authorization Date
- 30-01-2024
Trial design
open-label, none/not specified-controlled Phase I trial across 16 sites in Belgium, Finland, Sweden and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 109
Recruitment
- Planned Sample Size
- 109
- Recruitment Window Months
- 84
Geography
- Total Number Of Sites
- 16
- Total Number Of Participants
- 73
Belgium
- Latest Decision Or Authorization Date
- 30-01-2024
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Urology
- Contact Person Name
- Siska Van Bruwaene
- Contact Person Email
- Siska.vanbruwaene@azgroeninge.be
- Site Name
- Institut Jules Bordet
- Department Name
- Nuclear Medicine
- Contact Person Name
- Carlos Artigas Guix
- Contact Person Email
- carlos.artigas@hubruxelles.be
- Site Name
- UZ Leuven
- Department Name
- Nuclear Medicine
- Contact Person Name
- Karolien Goffin
- Contact Person Email
- karolien.goffin@uzleuven.be
Finland
- Latest Decision Or Authorization Date
- 30-05-2025
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Pohjois-Savon hyvinvointialue
- Department Name
- Department of Oncology, Kelkkailijantie 7
- Contact Person Name
- Okko Kääriäinen
- Contact Person Email
- okko.kaariainen@pshyvinvointialue.fi
- Site Name
- Tampere University Hospital
- Department Name
- Oncology and radiotherapy department
- Contact Person Name
- Minna Tanner
- Contact Person Email
- minna.tanner@pirha.fi
- Site Name
- Mehilaeinen Oy
- Department Name
- Docrates Mehiläinen cancer center
- Contact Person Name
- Leila Vaalavirta
- Contact Person Email
- leila.vaalavirta@docrates.com
- Site Name
- HUS-yhtymae
- Department Name
- Helsinki University Hospital Comprehensive cancer center, Clinical trial unit
- Contact Person Name
- Kalle Mattila
- Contact Person Email
- kalle.mattila@hus.fi
- Site Name
- Turku University Hospital
- Department Name
- Oncology department
- Contact Person Name
- Saana Virtanen
- Contact Person Email
- saana.maaria.virtanen@varha.fi
Sweden
- Latest Decision Or Authorization Date
- 14-05-2025
- Number Of Sites
- 4
- Number Of Participants
- 13
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Verksamhet onkologi, Bla Straket 5, 413 46 Goteborg
- Contact Person Name
- Edvard Abel
- Contact Person Email
- gothia.forum@vgregion.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- KFE Hematologi, onkologi och strålningsfysik, Lasarettsgatan 23, 221 85 Lund
- Contact Person Name
- Helena Nyström
- Contact Person Email
- studiesupport.sus@skane.se
- Site Name
- Karolinska University Hospital
- Department Name
- Fas 1-enheten Solna, CKC, Tema Cancer
- Contact Person Name
- Oscar Wiklander
- Contact Person Email
- forumstockholmgotland.karolinska@regionstockholm.se
- Site Name
- Uppsala University Hospital
- Department Name
- KFUE, Blod och tumörsjukdomar, Akademiska Sjukhuset, Uppsala
- Contact Person Name
- Ingrida Verbiene
- Contact Person Email
- kliniskaprovningar@akademiska.se
Netherlands
- Latest Decision Or Authorization Date
- 16-06-2025
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Medical Oncology
- Contact Person Name
- Debbie Robbrecht
- Contact Person Email
- TMonco.ctc@erasmusmc.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Medical Oncology
- Contact Person Name
- Daan Knapen
- Contact Person Email
- researchcoordinator@onco.umcg.nl
Italy
- Latest Decision Or Authorization Date
- 05-06-2025
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Nuclear Medicine
- Contact Person Name
- Secondo Lastoria
- Contact Person Email
- s.lastoria@istitutotumori.na.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Nuclear Medicine
- Contact Person Name
- Francesco Ceci
- Contact Person Email
- francesco.ceci@ieo.it
Sponsor
Primary sponsor
- Full Name
- Bayer Consumer Care AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- 225Ac-PSMA-Trillium (BAY 3563254)
- Modality
- Radiopharmaceutical
- First In Human
- Yes
Related trials
Other published trials that may interest you.
- Abiraterone acetate for Metastatic castration-resistant prostate cancer (mCRPC)
- LUXDEGALUTAMIDE for Metastatic castration-resistant prostate cancer (mCRPC)
- LUXDEGALUTAMIDE for Metastatic castration-resistant prostate cancer (mCRPC)
- Valemetostat for Metastatic castration-resistant prostate cancer (mCRPC)
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer