Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer (CRPC)
Public ClinicalTrials.gov record NCT06549465. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Open-label Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a four-part study evaluating the safety and efficacy of a PSMA-directed radioantibody (rosopatamab tetraxetan, conjugated to either In-111 or Ac-225). Part 1 will consist of one administration of In-111-rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and prostate cancer lesions. Participants then will be enrolled into either Part 2 (Dose Optimization) or Part 3 (Dose Escalation and Expansion) depending on their prior treatment history. Part 4 will be an extended regimen in dose escalation and expansion. Participants qualifying for Part 2 will be randomized to receive Ac-225 rosopatamab tetraxetan in a single fractionated cycle (dose administration on Day 1 and Day 15) at either 45 or 60 kBq/Kg. Participants qualifying for Part 3 must have received prior Lu-177-PSMA-radioligand therapy and will receive Ac-225 rosopatamab tetraxetan in a single fractionated cycle at 45, 55, or 60 kBq/Kg. Dose limiting toxicities (DLTs) will be monitored in Part 3 to determine the recommended phase 2 dose (RP2D), and the study may enroll additional participants to be treated with the RP2D dose level. Participants qualifying for Part 4 will initially receive two doses (dose administration on Day 1 and Day 15) at the dose level selected in Part 2, followed by a single third dose of Ac-225 rosopatamab tetraxetan administered approximately 12 weeks after completion of the Part 2 fractionated dosing regimen. The starting dose level for Part 4 will be 22 kBq/kg (or fixed activity equivalent). Dose limiting toxicities (DLTs) will be monitored following administration of the third dose in Part 4 to determine the recommended phase 2 dose (RP2D) of a third dose of Ac-225 rosopatamab tetraxetan. Participants enrolled into any part will attend study visits which will include blood samples, electrocardiogram (ECG), radiographic imaging, and physical examinations along with other assessments.
Study identification
- NCT ID
- NCT06549465
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 93 participants
Conditions and interventions
Interventions
- In-111 rosopatamab tetraxetan Biological
- 45 kBq/kg Ac-225 rosopatamab tetraxetan Biological
- 45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan Biological
- 60 kBq/kg Ac-225 rosopatamab tetraxetan Biological
- Single dose 22 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan Biological
- Single dose 34 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan Biological
- Single dose 45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan Biological
- 55 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan Biological
- 60 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 5, 2024
- Primary completion
- Apr 19, 2027
- Completion
- Apr 19, 2027
- Last update posted
- Jul 19, 2026
2024 – 2027
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego | San Diego | California | 92093 | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| Washington University in St. Louis | St Louis | Missouri | 63130 | Recruiting |
| X Cancer Omaha / Urology Cancer Center | Omaha | Nebraska | 68130-5606 | Recruiting |
| Laura & Isaac Perlmutter Cancer Center | New York | New York | 10016 | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| New York Presbyterian/Weill Cornell Medical Center | New York | New York | 10065 | Recruiting |
| Duke University Medical Center | Durham | North Carolina | 27710 | Recruiting |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06549465, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 19, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06549465 live on ClinicalTrials.gov.