Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-01-04 @ 4:10 AM
Study NCT ID:
NCT06634394
Status:
RECRUITING
Last Update Posted:
2025-05-11
First Post:
2024-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
Sponsor:
Aptevo Therapeutics
Organization:
Study Overview
Official Title:
A Phase 1b/2 Open-Label Study of APVO436 in Combination With Venetoclax and Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
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:
A multi-center, open-label, dose-finding study of five dose levels of APVO436 in combination with venetoclax and azacitidine (ven/aza) 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:
False
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?:
False
Is an FDA AA801 Violation?: