Back to resultsA Phase I Study of IGN523 in Subjects With Relapsed or Refractory AML
Primary Purpose
Acute Myelogenous Leukemia, Acute Myeloid Leukemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IGN523
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring Acute Myelogenous Leukemia, Acute Myeloid Leukemia, Drug therapy, CD98, Relapsed, Refractory, Monoclonal antibody
Eligibility 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
Sites / Locations
- UCSD Medical Center / Thornton Hospital
- Winship Cancer Institute, Emory University
- Indiana Blood and Marrow Transplantation Clinic
- University of Michigan Health System
- MD Anderson Cancer Center
- University of Washington
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IGN523
Arm Description
IGN523
Outcomes
Primary Outcome Measures
Incidence of adverse events
Secondary Outcome Measures
Incidence of antidrug antibodies to IGN523
Blood concentrations of IGN523
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.
Full Information
NCT ID
NCT02040506
First Posted
January 16, 2014
Last Updated
February 22, 2016
Sponsor
Igenica Biotherapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02040506
Brief Title
A Phase I Study of IGN523 in Subjects With Relapsed or Refractory AML
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Igenica Biotherapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia, Acute Myeloid Leukemia
Keywords
Acute Myelogenous Leukemia, Acute Myeloid Leukemia, Drug therapy, CD98, Relapsed, Refractory, Monoclonal antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IGN523
Arm Type
Experimental
Arm Description
IGN523
Intervention Type
Drug
Intervention Name(s)
IGN523
Intervention Description
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 Measure Information:
Title
Incidence of adverse events
Time Frame
Through 1 month following last dose
Secondary Outcome Measure Information:
Title
Incidence of antidrug antibodies to IGN523
Time Frame
Through 6 months following last dose
Title
Blood concentrations of IGN523
Time Frame
Through 6 months following last dose
Title
Assess anti-leukemic activity of IGN523
Description
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.
Time Frame
Initial assessment after 8 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Ho, MD, PhD
Organizational Affiliation
Igenica Biotherapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UCSD Medical Center / Thornton Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Indiana Blood and Marrow Transplantation Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase I Study of IGN523 in Subjects With Relapsed or Refractory AML
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