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FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) - Trial NCT06402331

Access comprehensive clinical trial information for NCT06402331 through Pure Global AI's free database. This Phase 2/3 trial is sponsored by Fusion Pharmaceuticals Inc. and is currently Recruiting. The study focuses on Metastatic Castration-resistant Prostate Cancer. Target enrollment is 60 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT06402331
Phase 2/3
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06402331
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FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Phase 2/3, 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), Previously Treated With 177Lu-PSMA Radioligand Therapy (RLT)

Study Focus

FPI-2265

Interventional

drug

Sponsor & Location

Fusion Pharmaceuticals Inc.

Omaha, United States of America

Timeline & Enrollment

Phase 2/3

Mar 05, 2024

Jan 23, 2031

60 participants

Primary Outcome

Frequency, duration, and severity of treatment-emergent adverse events (TEAEs),Frequency and proportion of participants with PSA50 response

Summary

This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I&T). The dose
 optimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor
 activity of novel dosing regimens of FPI-2265 in participants with PSMA-positive mCRPC who
 have been previously treated with 177Lu-PSMA-617 or another 177Lu-PSMA radioligand therapy
 (RLT).

ICD-10 Classifications

Malignant neoplasm of prostate
Hyperplasia of prostate
Carcinoma in situ: Prostate
Special screening examination for neoplasm of prostate
Dysplasia of prostate

Data Source

ClinicalTrials.gov

NCT06402331

Non-Device Trial