NCT02040506

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

A Phase 1, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Clinical Activity of IGN523 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Igenica Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-03-01
• Completion: 2015-06-01
• First posted: 2014-01-20
• Last updated: 2016-02-23

Locations

6 sites across 1 country: United States