FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Public ClinicalTrials.gov record NCT06402331. 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, Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of FPI-2265 (225Ac-PSMA-I&T) in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I\&T). Patient population is adult participants with PSMA positive mCRPC who have had previous treatment with with 177Lu-PSMA-617 or another 177Lu-PSMA radioconjugate (RC). The purpose of the study is to determine the safety and tolerability, and recommended dose and regiment of FPI-2265.
Study identification
- NCT ID
- NCT06402331
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 110 participants
Conditions and interventions
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
- Mar 4, 2024
- Primary completion
- Dec 22, 2026
- Completion
- Jan 22, 2031
- Last update posted
- Apr 7, 2026
2024 – 2031
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| Hoag Health Center Irvine | Irvine | California | 92618 | — |
| VA Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| UCSF School of Medicine | San Francisco | California | 94143 | — |
| Biogenix Molecular, LLC | Miami | Florida | 33165 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| United Theranostics | Glen Burnie | Maryland | 21061 | — |
| BAMF Health | Grand Rapids | Michigan | 49503 | — |
| SSM Health Saint Louis University Hospital | St Louis | Missouri | 63104 | — |
| XCancer | Omaha | Nebraska | 68130 | — |
| New Mexico Oncology Hematology Consultants Ltd. | Albuquerque | New Mexico | 87109 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| Memorial Sloan Kettering Cancer Center - NYC | New York | New York | 10065 | — |
| Oregon Health and Science University (OHSU, Knight Cancer Center) | Portland | Oregon | 97239-3098 | — |
| VA North Texas Health Care System, Nuclear Medicine Service | Dallas | Texas | 75216 | — |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| U.T. MD Anderson Cancer Center | Houston | Texas | 77030 | — |
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 NCT06402331, 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 Apr 7, 2026 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06402331 live on ClinicalTrials.gov.