Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237491
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-01-23
Brief Title:
The Safety and Dosimetry Study of 177Lu-LNC1003 Injection
Sponsor:
Yantai LNC Biotechnology Singapore PTE LTD
Organization:
Yantai LNC Biotechnology Singapore PTE LTD
Study Overview
Official Title:
Phase I Open-Label Study of the Safety and Dosimetry of a 3-Dose Regimen of Escalating Doses of 177Lu-LNC1003 Injection in Adult Patients With Prostate Specific Membrane Antigen PSMA-Positive Metastatic Castration-Resistant Prostate Cancer mCRPC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
This proposal is a phase I open-label study of a 3-Dose Regimen of Escalating Doses of 177Lu-LNC1003 Injection in patients with PSMA-positive mCRPC
In the clinical development we aim to demonstrate the following
1 Determination of the therapeutic doses to be used in the expansion phase
2 Demonstration of the safety and tolerability of 177Lu-LNC1003 at therapeutic doses
The treatment regimen will consist of a single-dose intravenous administration of 177Lu-LNC1003 Injection per 6-week cycle for a total of 2 cycles The dose per cycle will be fixed for each patient and will be escalated in 3 different dose levels
In the clinical development we aim to demonstrate the following
1 Determination of the therapeutic doses to be used in the expansion phase
2 Demonstration of the safety and tolerability of 177Lu-LNC1003 at therapeutic doses
The treatment regimen will consist of a single-dose intravenous administration of 177Lu-LNC1003 Injection per 6-week cycle for a total of 2 cycles The dose per cycle will be fixed for each patient and will be escalated in 3 different dose levels
Detailed Description:
This proposal is a phase I open-label study of a 3-Dose Regimen of Escalating Doses of 177Lu-LNC1003 Injection in patients with PSMA-positive mCRPC The treatment regimen will consist of a single-dose intravenous administration of 177Lu-LNC1003 Injection per 6-week cycle for a total of 2 cycles The dose per cycle will be fixed for each patient and will be escalated in 3 different dose levels from 30 mCi to 70 mCi 111 GBq - 259 GBq
This classic 33 design recruits 3 patients for the first dose level group If no dose limiting toxicity DLT occurs in the first cycle then 3 new patients will enter the next higher dose level If any DLT occurs at a certain dose level 3 additional patients will be enrolled at this current dose level in total 6 patients now to be assessed The highest dose levels at which less than one-third of patients eg 0 of 3 or 1 of 6 patients experience a DLT will be declared the maximum tolerated dose MTD If there is no MTD observed after the dose escalation up to 70 mCi a comprehensive evaluation should be made by investigator and sponsor to determine whether an escalation to a higher dose can be conducted or not based on the known safety data radiation doses for similar drugs documented in literature and treatment responses at the doses administered
This classic 33 design recruits 3 patients for the first dose level group If no dose limiting toxicity DLT occurs in the first cycle then 3 new patients will enter the next higher dose level If any DLT occurs at a certain dose level 3 additional patients will be enrolled at this current dose level in total 6 patients now to be assessed The highest dose levels at which less than one-third of patients eg 0 of 3 or 1 of 6 patients experience a DLT will be declared the maximum tolerated dose MTD If there is no MTD observed after the dose escalation up to 70 mCi a comprehensive evaluation should be made by investigator and sponsor to determine whether an escalation to a higher dose can be conducted or not based on the known safety data radiation doses for similar drugs documented in literature and treatment responses at the doses administered
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?:
None
Is an FDA AA801 Violation?:
None