Clinical trial NCT02040506: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myelogenous Leukemia
Acute Myeloid Leukemia
Keywords: Acute Myelogenous Leukemia
Acute Myeloid Leukemia
Drug therapy
CD98
Relapsed
Refractory
Monoclonal antibody
Lead sponsor: Igenica Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Through 1 month following last dose
Secondary outcomes:
measure: Incidence of antidrug antibodies to IGN523
timeFrame: Through 6 months following last dose
measure: Blood concentrations of IGN523
timeFrame: Through 6 months following last dose
measure: Assess anti-leukemic activity of IGN523
timeFrame: Initial assessment after 8 weeks of treatment
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Medical Center / Thornton Hospital
state: California
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana Blood and Marrow Transplantation Clinic
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Igenica Biotherapeutics, Inc.
name: William Ho, MD, PhD
role: STUDY_DIRECTOR
References: