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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 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.

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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.

Conditions Studied

Metastatic Castration-Resistant Prostate Cancer

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

FieldValue
Enrollment Target 100 participants
Start Date 2024-03-05
Est. Completion 2031-01-23
Phase Phase 2

Sponsor

Fusion Pharmaceuticals

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06402331

The ClinicalTrials.gov registry entry for NCT06402331 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 196-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (49% lower). The listed sponsor is Fusion Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 18 study locations spanning 11 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.