Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04597411
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2020-09-29
Brief Title:
Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer
Sponsor:
Endocyte
Organization:
Endocyte
Study Overview
Official Title:
AcTION A Phase I Study of 225AcAc-PSMA-617 in Men With PSMA-positive Prostate Cancer With or Without Prior 177LuLu-PSMA-617 Radioligand Therapy
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:
This is a Phase 1 open-label international dose escalation study to evaluate the safety of 225AcAc-PSMA-617 225Ac-PSMA-617 in men with PSMA-positive prostate cancer who have and have not had prior exposure to 177LuLu-PSMA-617 177Lu-PSMA-617 or 177LuLu-PSMA IT 177Lu-PSMA IT
Detailed Description:
The study schedule for each patient consists of a screening phase a treatment phase safety and long-term follow up phase for an overall individual duration of approximately 32 months
A minimum of 3 patients will be treated in each patient group at each dose level and evaluated for the occurrence of dose-limiting toxicity DLT during the first 6 weeks of treatment before consideration will be given to enrolling patients into the next dose level Dose modifications for toxicity are allowed beyond the first 6 weeks of therapy and defined per protocol
No more than 6 cycles of 225Ac-PSMA-617 will be administered Patients may receive less than 6 cycles if they have disease progression intolerable toxicity started other anticancer therapy or have withdrawn from treatment per subject or physician decision
Subjects may also receive supportive care therapy as determined by the investigative physician however subjects cannot receive concurrent investigational agents cytotoxic chemotherapy biological agents targeted therapy immunotherapy other systemic radioisotopes and hemi-body radiotherapy or novel androgen axis drugs ARPIs until completion of treatment with 225Ac-PSMA-617
A minimum of 3 patients will be treated in each patient group at each dose level and evaluated for the occurrence of dose-limiting toxicity DLT during the first 6 weeks of treatment before consideration will be given to enrolling patients into the next dose level Dose modifications for toxicity are allowed beyond the first 6 weeks of therapy and defined per protocol
No more than 6 cycles of 225Ac-PSMA-617 will be administered Patients may receive less than 6 cycles if they have disease progression intolerable toxicity started other anticancer therapy or have withdrawn from treatment per subject or physician decision
Subjects may also receive supportive care therapy as determined by the investigative physician however subjects cannot receive concurrent investigational agents cytotoxic chemotherapy biological agents targeted therapy immunotherapy other systemic radioisotopes and hemi-body radiotherapy or novel androgen axis drugs ARPIs until completion of treatment with 225Ac-PSMA-617
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| CAAA817A12101 | OTHER | Novartis | None |