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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)

StatusActive, Not Recruiting
PhasePhase 1
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary endpoints: details revised at 2 of 8 entries Trial sites reduced: 28 → 17 locations · Eligibility criteria expanded, about 37 words · Secondary endpoints: details revised at 7 of 11 entries · 1 more Show 4 more changesShow less
    • Trial sites reduced: 28 → 17 locations
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: details revised at 7 of 11 entries
    • Publications: details revised at 1 of 1 entry
  2. Minor Study sites revised (28)v40 See this version in full on ClinicalTrials.gov ↗
  3. Minor Re-verified, no change to tracked fieldsv39
  4. Minor Study sites revised (28)v38 See this version in full on ClinicalTrials.gov ↗
  5. Minor Study sites revised (28)v37 See this version in full on ClinicalTrials.gov ↗
Show 35 earlier versionsHide 35 earlier versions
  1. Minor Site details revised at 1 of 28 sitesv36
  2. Minor Study sites: 31 to 28v35
  3. Minor Re-verified, no change to tracked fieldsv34
  4. Minor Study sites revised (31)v33 See this version in full on ClinicalTrials.gov ↗
  5. Minor Trial status: Recruiting to Active, Not Recruiting Study sites: 32 to 31v32 Show 1 more changeShow less
    • Study sites: 32 to 31
  6. Minor Study sites revised (32)v31 See this version in full on ClinicalTrials.gov ↗
  7. Minor Eligibility criteria expanded, about 37 words Site details revised at 1 of 32 sitesv30 Show 1 more changeShow less
    • Site details revised at 1 of 32 sites

    See this version in full on ClinicalTrials.gov ↗

  8. Minor Site details revised at 5 of 32 sitesv29
  9. Minor Study sites: 30 to 32v28
  10. Minor Study sites: 31 to 30v27
  11. Minor Study sites: 30 to 31v26
  12. Minor Site details revised at 1 of 30 sitesv25
  13. Minor Study sites: 27 to 30v24
  14. Minor Re-verified, no change to tracked fieldsv23
  15. Minor Study sites revised (27) Study title revisedv22 Show 1 more changeShow less
  16. Minor Study sites: 15 to 27v21
  17. Minor Study sites: 12 to 15v20
  18. Minor Study sites: 11 to 12v19
  19. Minor Study sites: 10 to 11v18
  20. Notable Enrollment target: 140 to 232 Study sites: 6 to 10 · Interventions: BAY2315493 (Drug), BAY2616505 (Drug), BAY3546828 (Drug) to BAY3546828 (Drug) · Eligibility criteria expanded, about 258 words · 2 morev17 Show 5 more changesShow less
    • Study sites: 6 to 10
    • Interventions: BAY2315493 (Drug), BAY2616505 (Drug), BAY3546828 (Drug) to BAY3546828 (Drug)
    • Eligibility criteria expanded, about 258 words
    • Secondary endpoints revised (11)
    • Study arms: 5 to 4

    See this version in full on ClinicalTrials.gov ↗

  21. Minor Re-verified, no change to tracked fieldsv16
  22. Minor Site details revised at 1 of 6 sitesv15
  23. Minor Completion date: Jun 16, 2031 to Aug 10, 2031 Site details revised at 1 of 6 sitesv14 Show 1 more changeShow less
    • Site details revised at 1 of 6 sites
  24. Minor Re-verified, no change to tracked fieldsv13
  25. Minor Site details revised at 1 of 6 sitesv12
  26. Minor Site details revised at 1 of 6 sitesv11
  27. Minor Study sites: 5 to 6v10
  28. Minor 2 versions Re-verified since Apr 3, 2024, no change to tracked fieldsv8-v9
  29. Minor Site details revised at 1 of 5 sitesv7
  30. Minor 4 versions Re-verified since Nov 6, 2023, no change to tracked fieldsv3-v6
  31. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 4 to 5 · Start date changed from estimate of Sep 28, 2023 to Sep 20, 2023v2 Show 2 more changesShow less
    • Study sites: 4 to 5
    • Start date changed from estimate of Sep 28, 2023 to Sep 20, 2023
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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. Doctors keep track of all medical problems (also called adverse events) that participants have during the study, even if they do not think that they might be related to the study treatment. Anticancer activity is measured using cancer imaging techniques and change in blood level of a protein called PSA. PSA is made by normal and by cancerous cells in the body. The PSA level is taken as a marker for prostate cancer development and is usually elevated in participants with mCRPC. In addition, researchers want to find out how 225Ac-pelgi moves into, through and out of the body. The study will have two parts. The first part, called dose escalation, is done to find the most appropriate dose and schedule that can be given in the second part of the study. For this, each participant will receive one of the predefined increasing doses of 225Ac-pelgi as an infusion into the vein. All participants in part 2, called dose expansion, will receive the most appropriate dose and schedule identified from the first part of the study. More than one dose level or schedule from part 1 may be tested. Both the participants and the study team know what treatment the participants will take. Participants in this study will take the study treatment 225Ac-pelgi once in a period of 6 weeks called a cycle. Each participant will have 4 of these treatment cycles, if the participant benefits from the treatment. Each participant will be in the study for up to nearly six years, including a first test (screening) phase of a maximum of 30 days, up to 12 months of treatment depending on the participant's benefit, and a follow-up phase of 60 months after the end of treatment. The following visits to the study site are planned: 2 during the screening phase, 8 in the first treatment cycle, 7 in subsequent cycles, and a visit 6 to 12 weeks after the last dose. In the following 12 months, visits are planned every 6 weeks and during the next 48 months phone calls or clinic visits are planned approximately every 12 weeks. In addition, a sub study during the dose escalation part will gather information on the distribution of the study treatment in the body, the proportion that binds to the cancer cells, and the resulting radiation at the tumor site. During the study, the study team will: * Do physical examinations * Check vital signs such as blood pressure, heart rate, and body temperature * Take blood, and urine samples * Examine heart health using echocardiogram and electrocardiogram (ECG) * Take tumor samples * Track 225Ac-pelgi in the body using gamma imaging (generally available at all study sites) * Check the tumor status using PET (positron emission tomography), CT (computed tomography) or MRI (magnetic resonance imaging) and bone scan * Ask questions about the impact of the disease on the participants' wellbeing and activities of daily life (Eastern Cooperative Oncology Group Performance status (ECOG PS)).
Trial Details
NCT Number NCT06052306
Lead Sponsor Bayer
Conditions Metastatic Castration-resistant Prostate Cancer
Enrollment 232 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov