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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040506
• Other study ID #: IGN523-01
• Status: Completed
• Phase: Phase 1
• First received: January 16, 2014
• Last updated: February 22, 2016
• Start date: February 2014
• Est. completion date: June 2015

Study information

• Verified date: February 2016
• Source: Igenica Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Winship Cancer Institute, Emory University	Atlanta	Georgia
United States	MD Anderson Cancer Center	Houston	Texas
United States	Indiana Blood and Marrow Transplantation Clinic	Indianapolis	Indiana
United States	UCSD Medical Center / Thornton Hospital	La Jolla	California
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Igenica Biotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Through 1 month following last dose	Yes
Secondary	Incidence of antidrug antibodies to IGN523		Through 6 months following last dose	Yes
Secondary	Blood concentrations of IGN523		Through 6 months following last dose	No
Secondary	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	No