Study of APVO436 in Elderly or Unfit Patients With Newly Diagnosed AML

Summary

The goal of this Phase IB study is to evaluate the safety and tolerability of APVO436 in naïve elderly unfit patients with newly diagnosed primary AML at the RP2D level when it is used as an adjunct to the standard of care and obtain a preliminary assessment of the anti-leukemia activity of an APVO436-containing combination therapy. Study Objectives: \- Primary Objective: Evaluate the safety and tolerability of APVO436 at the RP2D level when it is used as an adjunct to the standard of care (venetoclax and azacitidine). \- Secondary Objectives: * Obtain a preliminary assessment of the anti-leukemia activity of APVO436-containing experimental triple drug combination therapy modalities. * Determine pharmacodynamics (PD) of APVO436, including changes in CD123 antigen density and measures of T cell number and function over time. * Determine correlations between response and MRD level and cytogenetic and molecular genetic profiles.

Timeline

Start

2025-01

Primary completion

2026-01

Completion

2027-01

Drugs

Indications