Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650605
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Phase 1 Open-label Study of 123I-ATT001 in Subjects with Relapsed Glioblastoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Citadel-123 a Phase I Clinical Trial to Assess the Activity of I-123 Poly Adenosine Diphosphate Ribose Polymerase I Inhibitor 123I-ATT001 Directly Administered in Subjects with Relapsed Glioblastoma
Status:
RECRUITING
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:
CITADEL-123
Brief Summary:
Phase I open-label trial of 123I-ATT001 monotherapy and in combination with treatment therapies in subjects with relapsed glioblastoma
Detailed Description:
The main goals of this study are to understand if 123I-ATT001 is safe and tolerable to treat participants with relapsed glioblastoma and to determine the maximum tolerated dose that can be given to participants without any unacceptable side effects
The study consists of two parts
- Part 1 is a dose escalation study where three doses of 123I-ATT001 will be tested starting with the lowest dose When a recommended dose RD has been declared a monotherapy expansion cohort will be open at that dose level
In Part 1 participants will receive a 123I-ATT001 dose once per week for four weeks two optional extra cycles
Part 2 is a dose expansion study where one dose of 123I-AT001 will be tested in combination with other therapies Part 2 will begin after the Part 1 has completed and a recommended part 2 dose has been chosen
The specific details and combination therapies for Part 2 of the study will be added via a protocol amendment at a later date
The study consists of two parts
- Part 1 is a dose escalation study where three doses of 123I-ATT001 will be tested starting with the lowest dose When a recommended dose RD has been declared a monotherapy expansion cohort will be open at that dose level
In Part 1 participants will receive a 123I-ATT001 dose once per week for four weeks two optional extra cycles
Part 2 is a dose expansion study where one dose of 123I-AT001 will be tested in combination with other therapies Part 2 will begin after the Part 1 has completed and a recommended part 2 dose has been chosen
The specific details and combination therapies for Part 2 of the study will be added via a protocol amendment at a later date
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