Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553846
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
A Clinial Trial of Lutetium 177Lu-FAP-75 for the Treatment of Patients With Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Clinical Trial on Pharmacokinetics and Radiation Dosimetry Safety and Preliminary Efficacy Evaluation of Lutetium 177Lu-FAP-75 for the Treatment of Patients With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
To explore the safety tolerability initial efficacy pharmacokinetic profile and radiation dosimetry of lutetium 177Lu-FAP-75 in the treatment of patients with advanced solid tumors
Detailed Description:
This is a prospective open dose-exploring clinical study of Lutetium 177Lu-FAP-75 in the treatment of patients with advanced solid tumors The study was divided into two stages the first stage was dose exploration study and the second stage was case expansion study In the first phase of this study several dose groups were designed Subjects may receive only one of these doses and may not receive multiple doses in the same subject The drug was administered every 6 weeks and the DLT observation period was 6 weeks after the first dose Firstly the first dose safety introduction of human body was carried out Based on the results of the preclinical study of this product an appropriate number of enrolled subjects in the first and second stages were selected to enter the PK and radiation dosimetry detection groups After the end of the DLT observation period subjects who met the criteria for continued dosing were allowed to continue to receive the investigational drug therapy for subsequent cycles For all participants enrolled in this study the study process included a screening period a treatment period and a follow-up period In the course of the trial extended studies of other tumor species can be conducted based on new advances and results of clinical studies of similar drugs to further explore the safety tolerability and initial effectiveness of specific tumor types
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