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

• Sponsor: Igenica Biotherapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02040506
• Collaborator: (none)
• Enrollment: 19
• Locations: 6
• Arm: 1
• Duration (Months): 15.9
• Patients Per Site: 3.2
• Patients Per Site Per Month: 0.2

Study Details

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.

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)

Study Design

• Study Type: Interventional
• 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: Feb 1, 2014
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Incidence of adverse events [Through 1 month following last dose]

Secondary Outcome Measures

1. Incidence of antidrug antibodies to IGN523 [Through 6 months following last dose]

2. Blood concentrations of IGN523 [Through 6 months following last dose]

3. Assess anti-leukemic activity of IGN523 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD Medical Center / Thornton Hospital	La Jolla	California	United States	92037
2	Winship Cancer Institute, Emory University	Atlanta	Georgia	United States	30322
3	Indiana Blood and Marrow Transplantation Clinic	Indianapolis	Indiana	United States	46237
4	University of Michigan Health System	Ann Arbor	Michigan	United States	48109
5	MD Anderson Cancer Center	Houston	Texas	United States	77030
6	University of Washington	Seattle	Washington	United States	98109

Sponsors and Collaborators

• Igenica Biotherapeutics, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Igenica Biotherapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02040506
• Other Study ID Numbers: IGN523-01
• First Posted: Jan 20, 2014
• Last Update Posted: Feb 23, 2016
• Last Verified: Feb 1, 2016

• Keywords provided by Igenica Biotherapeutics, Inc.: Acute Myelogenous Leukemia; Acute Myeloid Leukemia; Drug therapy; CD98; Relapsed; Refractory; Monoclonal antibody
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Feb 23, 2016