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Study identifier: NCT06217822 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)

Condition: Advanced Metastatic Castration-resistant Prostate Cancer · Prostate Specific Membrane Antigen (PSMA) Expression  ·  Sponsor: Bayer

PhasePhase 1
Planned participants198
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

Researchers are looking for a better way to treat participants who have metastatic castration-resistant prostate cancer (mCRPC). mCRPC is a cancer of the prostate (male reproductive gland found below the bladder) that has spread to other parts of the body. This type of prostate cancer does not respond to hormone treatment used to lower the level of testosterone, a male sex hormone, to prevent cancer from growing. The study treatment 225Ac-PSMA-Trillium, also called BAY3563254, is under development to treat advanced metastatic castration-resistant prostate cancer. It works by binding to PSMA and giving off radiation that can damage cancer cells and stop them from growing. The main purpose of this first-in-human study is to learn: * How safe is BAY3563254 in participants. * What is the recommended dose of BAY3563254 that is safe and works well that will be further tested in Part 2 of the study. * How well does BAY3563254 work in participants. To answer this, the researchers will look at: * The number and severity of medical problems including serious medical problems that participants experience after taking BAY3563254 * The number of dose-limiting toxicities (DLT) at each dose level. A DLT is a medical problem caused by a drug that is too severe to continue the use of that specific dose. * The number of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective resp…

This description comes directly from the study's public registry record.

Talk to the study team

Bayer Clinical Trials Contact  ·  (+)1-888-84 22937  ·  clinical-trials-contact@bayer.com

Always discuss trial participation with your own doctor first.

Locations (35)

City of Hope - Duarte Cancer CenterDuarte, California, United StatesNot Yet Recruiting
M Health Fairview Masonic Cancer Clinic - Clinics and Surgery CenterMinneapolis, Minnesota, United StatesNot Yet Recruiting
XCancer OmahaOmaha, Nebraska, United StatesNot Yet Recruiting
The University of Texas MD Anderson Cancer Center - Texas Medical CenterHouston, Texas, United StatesNot Yet Recruiting
Institut Jules Bordet / Nuclear MedicineAnderlecht, Brussels Capital, BelgiumRecruiting
UZ Leuven - Campus Gasthuisberg - Nuclear MedicineLeuven, Flemish Brabant, BelgiumNot Yet Recruiting
AZ Groeninge Campus Kennedylaan - UrologyKortrijk, West Flanders, BelgiumRecruiting
Cross Cancer Institute | Clinical Trials UnitEdmonton, Alberta, CanadaWithdrawn
BC Cancer | VancouverVancouver, British Columbia, CanadaRecruiting
Juravinski Cancer Centre | Clinical TrialsHamilton, Ontario, CanadaRecruiting
Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and HematologyToronto, Ontario, CanadaRecruiting
Centre Hospitalier de l'Universite de Montreal (CHUM) | OncologyMontreal, Quebec, CanadaRecruiting

+ 23 more locations — full list on the registry record.

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