NCT02040506 (Clinical Trial / IGN523)

Study Title
A Phase I Study of IGN523 in Subjects With Relapsed or Refractory AML (NCT02040506)

Trial Description
This study will examine the safety and tolerability of IGN523 administered as an IV infusion. The main purpose of the study is to determine the maximum tolerated dose (MTD), which is the highest dose that does not cause unacceptable side effects of IGN523 in patients with acute myeloid leukemia (AML).

The MTD will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of IGN523. In addition, the pharmacokinetic profile and anti-leukemia activity of IGN523 will be assessed. A recommended Phase II dose (RP2D) of IGN523 will be identified, on the basis of safety, pharmacokinetic (PK), and pharmacodynamic (PD) data.

This trial is sponsored by Igenica Biotherapeutics, Inc. [1]

Study Data

  • Condition: Leukemia
  • Interventions:
    • Drugs used in this trial
      • IGN523
  • Phase: I
  • Enrollment: 19
  • Start: February 2014
  • Estimated Completion: June 2015
  • Last verified: August 2014

Study Schematic 

(Coming soon)


Last Editorial review: July 8, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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