Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634394
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
APVO436 Phase 1b2 Study in Patients With Newly Diagnosed AML
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b2 Open-Label Study of APVO436 in Combination With Venetoclax and Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia AML
Status:
NOT_YET_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:
None
Brief Summary:
A multi-center open-label dose-finding study of five dose levels of APVO436 in combination with venetoclax and azacitidine venaza in adult patients with newly diagnosed CD123 AML
Detailed Description:
Phase 1b consists of 28-day cycles of treatment in five sequential cohorts In Cycle 1 C1 only to reduce the risk of CRS each cohort will receive 4 priming doses of APVO436 respectively APVO436 will be given in combination with venetoclax and azacitidine For C1D15 and all doses in each subsequent cycle cohorts will receive APVO436 at the determined cohort dose level
APVO436 dosing will be administered by a 4-hour intravenous IV infusion
APVO436 dosing will be administered by a 4-hour intravenous IV infusion
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