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

I

Igenica Biotherapeutics

Status and phase

Completed
Phase 1

Conditions

Acute Myelogenous Leukemia
Acute Myeloid Leukemia

Treatments

Drug: IGN523

Study type

Interventional

Funder types

Industry

Identifiers

NCT02040506
IGN523-01

Details and patient eligibility

About

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.

Full 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)

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 1 patient group

IGN523
Experimental group
Description:
IGN523
Treatment:
Drug: IGN523

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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