A Phase I Study of IGN523 in Subjects With Relapsed or Refractory AML

Completed · Phase 1

Conditions studied: Acute Myelogenous Leukemia, Acute Myeloid Leukemia

In brief

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 2 dose (RP2D) of IGN523 will be identified, on the basis of safety, pharmacokinetic (PK), and pharmacodynamic (PD) data.

Key facts

Study ID

NCT02040506

Run by

Igenica Biotherapeutics, Inc.

People needed

19

Starts

2014-02-01

Expected to finish

2015-06-01

Last updated by the study team

2016-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Relapsed or treatment-refractory AML
• Eastern Cooperative Oncology Group status 0-2
• Life expectancy of at least 12 weeks
• Adequate baseline renal and hepatic function
• Measurable disease (eg, peripheral blasts greater than 5%)

You may not qualify if…

• Chronic myelogenous leukemia in blast crisis
• Monoclonal therapy within 4 weeks, or chemotherapy or radiotherapy within 2 weeks
• Unresolved acute toxicity from prior anti-cancer therapy
• Prior allogeneic stem cell transplant and active graft-versus-host disease requiring systemic immunosuppressive therapy within 15 days prior to screening
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
• Known current leptomeningeal or central nervous system (CNS) involvement of leukemia

Where it is running

• UCSD Medical Center / Thornton Hospital — La Jolla, California, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• Indiana Blood and Marrow Transplantation Clinic — Indianapolis, Indiana, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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