Study of APVO436 in Elderly or Unfit Patients With Newly Diagnosed AML - Trial NCT04973618
Access comprehensive clinical trial information for NCT04973618 through Pure Global AI's free database. This Phase 1 trial is sponsored by Aptevo Therapeutics and is currently Withdrawn. The study focuses on AML. Target enrollment is 0 participants.
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Study Focus
Sponsor & Location
Aptevo Therapeutics
Timeline & Enrollment
Phase 1
Jan 01, 2025
Jan 01, 2027
Primary Outcome
Safety - Incidence of Grade 3-4 AEs and SAEs
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04973618
Non-Device Trial