Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-01 @ 10:05 AM
Study NCT ID:
NCT02040506
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2014-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of IGN523 in Subjects With Relapsed or Refractory AML
Sponsor:
Igenica Biotherapeutics, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
* 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)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: