Ignite Creation Date:
2024-07-17 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492122
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-24
Brief Title:
Study With 225AcAc-FL-020 in mCRPC Participants
Sponsor:
Full-Life Technologies GmbH
Organization:
Full-Life Technologies GmbH
Study Overview
Official Title:
A Phase 1 First-in-Human Open-label Study Evaluating the Safety Tolerability Pharmacokinetics and Efficacy of 225AcAc-FL-020 in Participants With mCRPC
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:
None
Brief Summary:
The purpose of this study is to evaluate the safety therapeutic effect and pharmacokinetics of 225AcAc-FL-020 in participants with metastatic castration-resistant prostate cancer mCRPC
Detailed Description:
The aim of this Phase 1 First-in-Human Open-label Trial is to evaluate the safety tolerability pharmacokinetics and efficacy of 225AcAc-FL-020 as a single agent in participants with metastatic Castration-Resistant Prostate Cancer mCRPC 111InIn-FL-020 serves as a surrogate for 225Ac-FL-020 for dosimetry purposes The trial is divided into two parts dose escalation in Part 1 and cohort expansion in Part 2
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?:
False
Is an FDA AA801 Violation?:
None