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NCT06052306 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn How Safe the Study Treatment Actinium-225-macropa-pelgifatamab (BAY3546828) is, How it Affects the Body, How it Moves Into, Through and Out of the Body, and About Its Anticancer Activity in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Bayer.
- Active
- Registry status
- Phase 1
- Development phase
- 232
- Enrollment target
- 20
- Study locations
NCT06052306: Active Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Bayer.
NCT06052306 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer that is active but no longer recruiting, run by Bayer. The registered enrollment target is 232 participants, above the 195-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (19% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06052306, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, is active but no longer recruiting, sponsored by Bayer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 232 participants
- Enrollment target
- 20
- Study locations
Study Summary
Researchers are looking for a better way to treat people who have advanced metastatic castration-resistant prostate cancer (mCRPC). In participants with metastatic castration-resistant prostate cancer (mCRPC), the cancer of the prostate has spread to other parts of the body (metastatic) and does not respond to the lowering of testosterone levels in the body (castration resistant). The cancer is 'advanced' and is unlikely to be cured or controlled with currently available treatments. Despite new treatment options for participant(s) with prostate cancer in recent years, the cancer often returns and worsens. The study treatment actinium-225-macropa-pelgifatamab (also called 225Ac-pelgi or BAY3546828) is a new type of treatment under development for participants with mCRPC who have already received available treatments or have few treatment options available. It works by binding to a protein on the surface of the cancer cells called prostate specific membrane antigen (PSMA). As it gives off a type of radioactivity that travels a very short distance, it kills the nearby (cancer) cells that express PSMA. The main purpose of this first-in-human study in participants with mCRPC is to learn: * How safe different doses of 225Ac-pelgi are. * To what degree medical problems caused by 225Ac-pelgi can be tolerated by the participants? * Which dose of 225Ac-pelgi is optimal for treatment (safe and working well)? * How good is 225Ac-pelgi's anticancer activity? To answer this, the researchers will look at: * The number and severity of medical problems that the participants have after treatment with 225Ac-pelgi (per dose level). * The ratio of medical problems and anticancer activity per dose. * Anticancer activity of the optimal 225Ac-pelgi dose as proportion of participants who have at least halved prostate-specific antigen (PSA) levels after 12 weeks of treatment or later and/or shrunken or no longer detectable tumors. * The lowest PSA level reached after treatment start. D
Conditions Studied
Interventions
- DRUG BAY3546828
Study Locations (20)
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
Other
- Istituto Europeo di Oncologia s.r.l - Medicina Nucleare - Milan
- IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Medicina Nucleare e Terapia Metabolica - Naples
- Universitair Medisch Centrum Groningen - Groningen
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
Utah
- Utah Cancer Specialists Cancer Center - Medical Oncology - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2023-09-20 |
| Est. Completion | 2031-08-10 |
| Phase | Phase 1 |
What the registry record for NCT06052306 still lists
NCT06052306 is an interventional study that assigns participants to a tested intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap, above the 195-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (19% higher).
The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which BAY3546828 is the first listed.
NCT06052306 names 20 study sites across 15 states, led by Quebec, Other, Uusimaa.
Frequently Asked Questions
What is clinical trial NCT06052306 about?
NCT06052306 is a clinical study titled "A Study to Learn How Safe the Study Treatment Actinium-225-macropa-pelgifatamab (BAY3546828) is, How it Affects the Body, How it Moves Into, Through and Out of the Body, and About Its Anticancer Activity in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)". Researchers are looking for a better way to treat people who have advanced metastatic castration-resistant prostate cancer (mCRPC). In participants with metastatic castration-resistant prostate cancer (mCRPC), the cancer of the prostate has spread to other parts of the body (metastatic) and does not...
What is the current status of trial NCT06052306?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 232 participants. The study started on 2023-09-20. Estimated completion is 2031-08-10.
What conditions does trial NCT06052306 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT06052306?
The interventions under investigation include: BAY3546828 (DRUG).
Who is sponsoring clinical trial NCT06052306?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06052306 being conducted?
This trial has 20 study locations across California, Minnesota, Nebraska, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT06052306's enrollment target sits among peer trials
232 16th of 69 higher than 54 of 69 other Metastatic Castration-Resistant Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer 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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