Acute Myelogenous LeukemiaPhase 1NCT02040506
A Phase I Study of IGN523 in Subjects With Relapsed or Refractory AML
A Phase 1 study testing IGN523 in people with Acute Myelogenous Leukemia and Acute Myeloid Leukemia, run by Igenica Biotherapeutics, Inc. at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia, Acute Myeloid Leukemia
- What is being tested?
- IGN523
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2014to Jun 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
MD Anderson Cancer Center
Houston, Texas, 77030
Indiana Blood and Marrow Transplantation Clinic
Indianapolis, Indiana, 46237
UCSD Medical Center / Thornton Hospital
La Jolla, California, 92037
University of Washington
Seattle, Washington, 98109
About this study
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
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.
Read the 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
- Being tested
- IGN523
- Keywords
- Acute Myelogenous Leukemia, Acute Myeloid Leukemia, Drug therapy, CD98, Relapsed, Refractory, Monoclonal antibody
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| IGN523 | Experimental | IGN523 Receives: Drug: IGN523 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Through 1 month following last dose
Secondary outcomes (3)
Incidence of antidrug antibodies to IGN523
Measured: Through 6 months following last dose
Blood concentrations of IGN523
Measured: Through 6 months following last dose
Assess anti-leukemic activity of IGN523
Subjects with measurable disease will be assessed by standard criteria (Cheson). Subjects will be formally evaluated for response at the end of Cycle 2; additional evaluations may be performed during the study as clinical indicated.
Measured: Initial assessment after 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igenica Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Ho, MD, PhD, Study director, Igenica Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040506
- Sponsor's protocol ID
- IGN523-01
- Status last verified
- Feb 2016
- First submitted
- 16 Jan 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02040506
- Acronym / sponsor ID
- IGN523-01
- Conditions
- Acute Myelogenous Leukemia, Acute Myeloid Leukemia
- Keywords
- Acute Myelogenous Leukemia, Acute Myeloid Leukemia, Drug therapy, CD98, Relapsed, Refractory, Monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Igenica Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IGN523 | Experimental | Drug: IGN523IGN523 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGN523Given intravenously every week for 8 weeks. Dosing beyond 8 weeks will be permitted for subjects meeting criteria for ongoing clinical benefit and acceptable safety. | Drug | IGN523 |
Primary outcome
Incidence of adverse events
Time frame: Through 1 month following last dose
3 secondary outcomes
Incidence of antidrug antibodies to IGN523
Time frame: Through 6 months following last dose
Blood concentrations of IGN523
Time frame: Through 6 months following last dose
Assess anti-leukemic activity of IGN523
Time frame: Initial assessment after 8 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Ho, MD, PhD study director
Igenica Biotherapeutics, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IGN523 in people with Acute Myelogenous Leukemia and Acute Myeloid Leukemia, run by Igenica Biotherapeutics, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Through 1 month following last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.