NCT06634394

APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Aptevo Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	APVO436	Infusion drug administered as a 4 hour infusion.
DRUG	Venetoclax	Oral tablet given on days 1 through 22, of a 28 day cycle.
DRUG	Azacitidine	Intravenous infusion given on days 1-8 of a 28 day cycle

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-10-01
• Completion: 2028-03-01
• First posted: 2024-10-09
• Last updated: 2025-05-11

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study