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

Igenica Biotherapeutics

Status and phase

Completed

Phase 1

Conditions

Acute Myelogenous Leukemia

Acute Myeloid Leukemia

Treatments

Drug: IGN523

Study type

Interventional

Funder types

Industry

Identifiers

NCT02040506

IGN523-01

Details and patient eligibility

About

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.

Full description

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)

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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