APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
NCT06634394 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2025-05-11
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.
Conditions
- Acute Myeloid Leukemia (AML)
Interventions
- DRUG
-
APVO436
Infusion drug administered as a 4 hour infusion.
- DRUG
-
Oral tablet given on days 1 through 22, of a 28 day cycle.
- DRUG
-
Intravenous infusion given on days 1-8 of a 28 day cycle
Sponsors & Collaborators
-
Aptevo Therapeutics
lead INDUSTRY
Principal Investigators
-
Dirk Huebner, MD · Aptevo Therapeutics
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-01
- Primary Completion
- 2027-10-31
- Completion
- 2028-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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