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

A Phase 1, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Clinical Activity of IGN523 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia; Acute Myelogenous Leukemia
• Intervention / Treatment: Drug: IGN523

Detailed 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)

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • UCSD Medical Center / Thornton Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute, Emory University
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Indiana Blood and Marrow Transplantation Clinic
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IGN523	Drug: IGN523; Given intravenously every week for 8 weeks. Dosing beyond 8 weeks will be permitted for subjects meeting criteria for ongoing clinical benefit and acceptable safety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	Through 1 month following last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of antidrug antibodies to IGN523		Through 6 months following last dose
Blood concentrations of IGN523		Through 6 months following last dose
Assess anti-leukemic activity of IGN523	Subjects with measurable disease will be assessed by standard criteria (Cheson). Subjects will be formally evaluated for response at the end of Cycle 2; additional evaluations may be performed during the study as clinical indicated.	Initial assessment after 8 weeks of treatment

Collaborators and Investigators

• Sponsor: Igenica Biotherapeutics, Inc.
• Investigators: Study Director: William Ho, MD, PhD, Igenica Biotherapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 16, 2014
• First Submitted That Met QC Criteria: January 16, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Estimate): February 23, 2016
• Last Update Submitted That Met QC Criteria: February 22, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Monoclonal antibody; Acute Myeloid Leukemia; Drug therapy; Relapsed; Refractory; Acute Myelogenous Leukemia; CD98
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: IGN523-01