Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641219
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Clinical Evaluation of 177LuLu-BQ7876 for Targeting of Prostate-Specific Membrane Antigen
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Evaluation of Lutetium-177 Labeled BQ7876 for Targeting of Prostate-Specific Membrane Antigen
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study should evaluate the biological distribution of 177LuLu-BQ7876 in patients with prostate cancer
The objective are
1 To evaluate the content of 177LuLu-BQ7876 in the blood of patients with prostate cancer at different time points after a single intravenous administration
2 To assess the distribution of 177LuLu-BQ7876 in normal tissues and tumors at different time points
3 To evaluate dosimetry of 177LuLu-BQ7876
4 To study the safety and tolerability of the drug 177LuLu-BQ7876 after a single injection
The objective are
1 To evaluate the content of 177LuLu-BQ7876 in the blood of patients with prostate cancer at different time points after a single intravenous administration
2 To assess the distribution of 177LuLu-BQ7876 in normal tissues and tumors at different time points
3 To evaluate dosimetry of 177LuLu-BQ7876
4 To study the safety and tolerability of the drug 177LuLu-BQ7876 after a single injection
Detailed Description:
The overall goal is to study the effectiveness of prostate-specific membrane antigen targeting using Lutetium-177 - labeled BQ7876
Phase I of the study
Biodistribution dosimetry safety and tolerability of 177LuLu-BQ7876 in patients with prostate cancer
The main objectives of the study
1 To evaluate the content of 177LuLu-BQ7876 in the blood of patients with prostate cancer at different time points after a single intravenous administration
2 To evaluate the distribution of 177LuLu-BQ7876 in normal tissues and tumors in patients with prostate cancer at different time points after a single intravenous administration
3 To evaluate dosimetry of 177LuLu-BQ7876 based on the pharmacokinetic parameters of the drug after a single intravenous administration
4 To study the safety of use and tolerability of the drug 177LuLu-BQ7876 after a single intravenous administration in a diagnostic dosage
Methodology
Open-label exploratory single centre study The subjects will receive a single injection of the labeled tracer
Phase I of the study
Biodistribution dosimetry safety and tolerability of 177LuLu-BQ7876 in patients with prostate cancer
The main objectives of the study
1 To evaluate the content of 177LuLu-BQ7876 in the blood of patients with prostate cancer at different time points after a single intravenous administration
2 To evaluate the distribution of 177LuLu-BQ7876 in normal tissues and tumors in patients with prostate cancer at different time points after a single intravenous administration
3 To evaluate dosimetry of 177LuLu-BQ7876 based on the pharmacokinetic parameters of the drug after a single intravenous administration
4 To study the safety of use and tolerability of the drug 177LuLu-BQ7876 after a single intravenous administration in a diagnostic dosage
Methodology
Open-label exploratory single centre study The subjects will receive a single injection of the labeled tracer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None