Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-31 @ 2:23 PM
Study NCT ID:
NCT06441994
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2024-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Targeted Alpha Therapy Using [At-211]PSMA-5 for Prostate Cancer
Sponsor:
Osaka University
Organization:
Study Overview
Official Title:
A Phase I Investigator-initiated Clinical Trial of a Novel Targeted Alpha Therapy Using [At-211]PSMA-5 for Patients With Castration-resistant Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2025-07
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:
Alpha-PS1
Brief Summary:
PSW-1025 is administered intravenously to patients with castration-resistant prostate cancer to evaluate its tolerability, safety, pharmacokinetics, absorbed dose, and efficacy, as well as to determine the recommended dose for Phase II.
Detailed Description:
PSW-1025 is administered intravenously to patients with castration-resistant prostate cancer to evaluate its tolerability, safety, pharmacokinetics, absorbed dose, and efficacy, as well as to determine the recommended dose for Phase II. PSW-1025 (\[At-211\]PSMA-5) is an alpha-ray-emitting drug labeled with Astatine (At-211) that targets PSMA (Prostate Specific Membrane Antigen).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: