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NCT06217822 · ClinicalTrials.gov registry record · Phase 1
First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Phase 1 study of Advanced Metastatic Castration Resistant Prostate Cancer and Prostate Specific Membrane Antigen (PSMA) Expression, sponsored by Bayer.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 198
- Enrollment target
- 20
- Study locations
NCT06217822: Recruiting Phase 1 study of Advanced Metastatic Castration Resistant Prostate Cancer and Prostate Specific Membrane Antigen (PSMA) Expression, sponsored by Bayer.
NCT06217822 is a Phase 1 study of Advanced Metastatic Castration Resistant Prostate Cancer and Prostate Specific Membrane Antigen (PSMA) Expression that is actively recruiting participants, run by Bayer. The registered enrollment target is 198 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (230% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06217822, a Phase 1 study of Advanced Metastatic Castration Resistant Prostate Cancer and Prostate Specific Membrane Antigen (PSMA) Expression, is actively recruiting participants, sponsored by Bayer.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 198 participants
- Enrollment target
- 20
- Study locations
Study Summary
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 response rate (ORR)) * The number of participants who have a decrease in the levels of PSA\* by at least 50% in their blood (also known as PSA50). PSA is a protein made by the prostate gland. High levels of PSA may indicate the presence of prostate cancer. * Participants' best response to treatment based on their PSA levels (also known as the best overall PSA response). The study will have two parts. The first part, called dose escalation, is done to find the most appropriate dose of BAY3563254 for
Primary Outcome
TEAE: Treatment-emergent adverse event TESAE: Treatment-emergent serious adverse event
Conditions Studied
Interventions
- DRUG 225Ac-PSMA-Trillium (BAY3563254)
Study Locations (20)
Other
- Institut Jules Bordet / Nuclear Medicine - Anderlecht
- AZ Groeninge Campus Kennedylaan - Urology - Kortrijk
- UZ Leuven - Campus Gasthuisberg - Nuclear Medicine - Leuven
- Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS) - Syöpäkeskus - Tampere
- Turku University Hospital, Turun yliopistollinen sairaala (TYKS) - Turku
- Istituto Europeo di Oncologia s.r.l - Medicina Nucleare - Milan
Quebec
- Centre Hospitalier de l'Universite de Montreal (CHUM) - Montreal
- McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM) - Montreal
- Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital Fleurimont - Sherbrooke
Ontario
- Juravinski Cancer Centre - Clinical Trials Department - Hamilton
- Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology - Toronto
Uusimaa
- HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Syöpäkeskus - Helsinki
- Docrates Mehiläinen Syöpäsairaala - Helsinki
California
- City of Hope - Duarte Cancer Center - Duarte
Minnesota
- M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center - Minneapolis
Nebraska
- XCancer Omaha - Omaha
Texas
- The University of Texas MD Anderson Cancer Center - Texas Medical Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2024-03-07 |
| Est. Completion | 2031-05-24 |
| Phase | Phase 1 |
What NCT06217822 shows while recruiting
NCT06217822 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (230% higher).
The record links to 2 conditions, with Advanced Metastatic Castration Resistant Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which 225Ac-PSMA-Trillium (BAY3563254) is the first listed.
NCT06217822 names 20 study sites across 11 states, led by Other, Quebec, Ontario.
Frequently Asked Questions
What is clinical trial NCT06217822 about?
NCT06217822 is a clinical study titled "First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)". 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 resp...
What is the current status of trial NCT06217822?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 198 participants. The study started on 2024-03-07. Estimated completion is 2031-05-24.
What conditions does trial NCT06217822 study?
This clinical trial studies the following conditions: Advanced Metastatic Castration Resistant Prostate Cancer, Prostate Specific Membrane Antigen (PSMA) Expression.
What interventions are being tested in trial NCT06217822?
The interventions under investigation include: 225Ac-PSMA-Trillium (BAY3563254) (DRUG).
Who is sponsoring clinical trial NCT06217822?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06217822 being conducted?
This trial has 20 study locations across California, Minnesota, Nebraska, Texas, Alberta. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Metastatic Castration Resistant Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06217822's enrollment target sits among peer trials
198 277th of 2000 higher than 1,723 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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