NCT02040506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

1.1 years

First QC Date

January 16, 2014

Last Update Submit

February 22, 2016

Conditions

Acute Myelogenous LeukemiaAcute Myeloid Leukemia

Keywords

Acute Myelogenous LeukemiaAcute Myeloid LeukemiaDrug therapyCD98RelapsedRefractoryMonoclonal antibody

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    Through 1 month following last dose

Secondary Outcomes (3)

  • Incidence of antidrug antibodies to IGN523

    Through 6 months following last dose

  • Blood concentrations of IGN523

    Through 6 months following last dose

  • Assess anti-leukemic activity of IGN523

    Initial assessment after 8 weeks of treatment

Study Arms (1)

IGN523

EXPERIMENTAL

IGN523

Drug: IGN523

Interventions

IGN523DRUG

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.

IGN523

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UCSD Medical Center / Thornton Hospital

La Jolla, California, 92037, United States

Location

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

Location

Indiana Blood and Marrow Transplantation Clinic

Indianapolis, Indiana, 46237, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteRecurrence

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • William Ho, MD, PhD

    Igenica Biotherapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 20, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

US(6)