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

Primary Objectives:

• Evaluate the safety and tolerability of IGN523 administered weekly
• Determine the MTD and dose limiting toxicity (DLT) of IGN523 when administered weekly during the DLT Evaluation Period
• Identify a recommended Phase 2 dose (RP2D) of IGN523 on the basis of safety, PK, and PD data

Secondary Objectives:

• Assess the incidence of antibody formation to IGN523
• Characterize the PK of IGN523 in subjects with relapsed or refractory AML
• Perform a preliminary assessment of the anti-leukemic activity of IGN523 in subjects with relapsed or refractory AML
• Perform a preliminary assessment of biologic markers that might predict IGN523 anti-leukemic activity

Estimated Enrollment: 50 Study Start Date: February 2014 Estimated Study Completion Date: March 2016 Estimated Primary Completion Date: September 2015 (Final data collection for primary outcome measure)

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