Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402331
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-04-26
Brief Title:
FPI-2265 225Ac-PSMA-IT for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer mCRPC
Sponsor:
Fusion Pharmaceuticals Inc
Organization:
Fusion Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 23 Randomized Open-Label Multicenter Study to Evaluate the Safety and Efficacy of FPI-2265 225Ac-PSMA-IT in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer mCRPC Previously Treated With 177Lu-PSMA Radioligand Therapy RLT
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AlphaBreak
Brief Summary:
This is an open-label randomized multicenter study of FPI-2265 225Ac-PSMA-IT 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
Detailed Description:
The purpose of the dose optimization segment Phase 2 is to determine the recommended FPI-2265 dose and regimen Conclusions from Phase 2 will be based on safety tolerability and anti-tumor activity
Participants with PSMA positive scans will be randomized 111 to one of three different dosing arms
Arm 1 Will consist of nine doses of FPI-2265 administered every four weeks at 50 kBqkg
Arm 2 Will consist of six doses of FPI-2265 administered every six weeks at 75 kBqkg
Arm 3 Will consist of four doses of FPI-2265 administered every eight weeks at 100 kBqkg
Participants will be monitored and assessed for efficacy response disease progression and adverse events
Participants with PSMA positive scans will be randomized 111 to one of three different dosing arms
Arm 1 Will consist of nine doses of FPI-2265 administered every four weeks at 50 kBqkg
Arm 2 Will consist of six doses of FPI-2265 administered every six weeks at 75 kBqkg
Arm 3 Will consist of four doses of FPI-2265 administered every eight weeks at 100 kBqkg
Participants will be monitored and assessed for efficacy response disease progression and adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None