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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)
NCT06052306 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06052306
The ClinicalTrials.gov registry entry for NCT06052306 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 232 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06052306 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Quebec, Other, Uusimaa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06052306?
The interventions under investigation include: BAY3546828 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06052306?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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