Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04509557
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2020-07-07
Brief Title:
177LuLudotadipep Treatment in Patients With Metastatic Castration-resistant Prostate Cancer
Sponsor:
FutureChem
Organization:
FutureChem
Study Overview
Official Title:
177LuLudotadipep Treatment in Patients With Metastatic Castration-resistant Prostate Cancer Phase I Clinical Trial
Status:
COMPLETED
Status Verified Date:
2022-10
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:
None
Brief Summary:
The study aims to evaluate the stability and efficacy after administration of 177LuLudotadipep in patients with metastatic castration resistant prostate cancer mCRPC with dose-escalation applied to determine the appropriate dose
Detailed Description:
18FPSMA PETCT is conducted at the 2nd screening and only PSMA PETCT positive patients can be enrolled PSMA RADS 4 or more
Dose is administered by differentiated into 5 groups 6 subjects each and sequentially elevated starting from a low dose to a high dose 505 mCi 758 mCi 10010 mCi 12513 mCi 15015 mCi
Dose is administered by differentiated into 5 groups 6 subjects each and sequentially elevated starting from a low dose to a high dose 505 mCi 758 mCi 10010 mCi 12513 mCi 15015 mCi
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None