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NCT06402331 · ClinicalTrials.gov registry record · Phase 2
FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Fusion Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 18
- Study locations
NCT06402331: Recruiting Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Fusion Pharmaceuticals.
NCT06402331 is a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by Fusion Pharmaceuticals. The registered enrollment target is 100 participants, below the 196-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (49% lower). The trial reports 18 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06402331, a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by Fusion Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 18
- Study locations
Study Summary
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.
Primary Outcome
Frequencies and percentages of participants with TEAEs will be summarized. Analysis will also be completed regarding duration of TEAEs and their severity.
Conditions Studied
Interventions
- DRUG FPI-2265
Study Locations (18)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Hoag Health Center Irvine - Irvine
- VA Greater Los Angeles Healthcare System - Los Angeles
- University of California Los Angeles - Los Angeles
- UCSF School of Medicine - San Francisco
Texas
- VA North Texas Health Care System, Nuclear Medicine Service - Dallas
- The University of Texas Southwestern Medical Center - Dallas
- U.T. MD Anderson Cancer Center - Houston
New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
- Memorial Sloan Kettering Cancer Center - NYC - New York
Florida
- Biogenix Molecular, LLC - Miami
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Maryland
- United Theranostics - Glen Burnie
Michigan
- BAMF Health - Grand Rapids
Missouri
- SSM Health Saint Louis University Hospital - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-03-05 |
| Est. Completion | 2031-01-23 |
| Phase | Phase 2 |
What NCT06402331 shows while recruiting
NCT06402331 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 196-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which FPI-2265 is the first listed.
NCT06402331 lists 18 locations in 11 states (California, Texas, New York).
Frequently Asked Questions
What is clinical trial NCT06402331 about?
NCT06402331 is a clinical study titled "FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)". 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 safet...
What is the current status of trial NCT06402331?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2024-03-05. Estimated completion is 2031-01-23.
What conditions does trial NCT06402331 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT06402331?
The interventions under investigation include: FPI-2265 (DRUG).
Who is sponsoring clinical trial NCT06402331?
This trial is sponsored by Fusion Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06402331 being conducted?
This trial has 18 study locations across California, Florida, Iowa, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06402331's enrollment target sits among peer trials
100 28th of 69 higher than 41 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.
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