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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Igenica Biotherapeutics, Inc.

Criteria

Inclusion Criteria:

• 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%)

Exclusion Criteria:

• 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