Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379217
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-03-04
Brief Title:
NEPC Study An Exploratory Safety and Efficacy Study With PSMA SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase I Open-label Multi-center Exploratory Safety and Efficacy Study With PSMA SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
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 purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells Prostate Specific Membrane Antigen PSMA Somatostatin Receptor 2 SSTR2 and Gastrin Releasing Peptide Receptor GRPR between the start and after the completion of radioligand therapy RLT Study will use radioligand imaging RLI to determine predominantly expressed target on the surface of tumor cells Based on predominant expression of target corresponding RLT targeting PSMA SSTR2 or GRPR RLT will be given for up to 6 cycles every 6 weeks as intravenous iv injection in participants with metastatic neuroendocrine prostate cancer mNEPC
Detailed Description:
The screening period for each subject includes imaging with 3 radioligand imaging RLI compounds to assess expression level of PSMA SSTR2 and GRPR Participants will be assigned to the radioligand treatment RLT corresponding to their predominantly expressed target based on blinded independent central review BICR During the treatment period participants will receive up to 6 cycles of the assigned RLT corresponding to a total dose of 444 GBq -10 for 177LuLu-PSMA-617 or 177LuLu-DOTA-TATE and 555 GBq -10 for 177LuLu-NeoB No crossover to a different type of RLT is allowed
At end of treatment EoT with RLT participants will be scanned again with the 3 RLIs All EoT PETCT scans should be performed using the same PETCT camera acquisition and reconstruction protocols as used for screening PETCT for the participant
The post-treatment follow-up period consists of a 42-days post EoT safety follow-up visit and long-term follow-up until radiographic disease progression death lost to follow-up or withdrawal of consent whichever occurs first
The planned duration of treatment is up to 36 weeks for all treatment arms in this study with treatment given every 6 weeks Participants may be discontinued from treatment earlier due to unacceptable toxicity or disease progression andor at the discretion of the Investigator or the participant
At end of treatment EoT with RLT participants will be scanned again with the 3 RLIs All EoT PETCT scans should be performed using the same PETCT camera acquisition and reconstruction protocols as used for screening PETCT for the participant
The post-treatment follow-up period consists of a 42-days post EoT safety follow-up visit and long-term follow-up until radiographic disease progression death lost to follow-up or withdrawal of consent whichever occurs first
The planned duration of treatment is up to 36 weeks for all treatment arms in this study with treatment given every 6 weeks Participants may be discontinued from treatment earlier due to unacceptable toxicity or disease progression andor at the discretion of the Investigator or the participant
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505655-43 | EUDRACT_NUMBER | None | None |