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

NCT ID: NCT02040506

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-06-30

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)

Conditions

Acute Myelogenous Leukemia; Acute Myeloid Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IGN523

IGN523

Group Type: EXPERIMENTAL

IGN523

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Igenica Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Ho, MD, PhD

Role: STUDY_DIRECTOR

Igenica Biotherapeutics, Inc.

Locations

UCSD Medical Center / Thornton Hospital

La Jolla, California, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Indiana Blood and Marrow Transplantation Clinic

Indianapolis, Indiana, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

IGN523-01

Identifier Type: -

Identifier Source: org_study_id