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

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ClinicalTrials.gov Identifier: NCT02040506
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Igenica Biotherapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Acute Myeloid Leukemia Drug: IGN523 Phase 1

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Clinical Activity of IGN523 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Study Start Date : February 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2015


Arm Intervention/treatment
Experimental: IGN523
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.




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Through 1 month following last dose ]

Secondary Outcome Measures :
  1. Incidence of antidrug antibodies to IGN523 [ Time Frame: Through 6 months following last dose ]
  2. Blood concentrations of IGN523 [ Time Frame: Through 6 months following last dose ]
  3. Assess anti-leukemic activity of IGN523 [ Time Frame: Initial assessment after 8 weeks of treatment ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040506


Locations
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United States, California
UCSD Medical Center / Thornton Hospital
La Jolla, California, United States, 92037
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana Blood and Marrow Transplantation Clinic
Indianapolis, Indiana, United States, 46237
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Igenica Biotherapeutics, Inc.
Investigators
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Study Director: William Ho, MD, PhD Igenica Biotherapeutics, Inc.
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Responsible Party: Igenica Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02040506    
Other Study ID Numbers: IGN523-01
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Keywords provided by Igenica Biotherapeutics, Inc.:
Acute Myelogenous Leukemia
Acute Myeloid Leukemia
Drug therapy
CD98
Relapsed
Refractory
Monoclonal antibody
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms