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CompletedNCT02732184Updated Aug 13, 2026

A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS

A Phase 1 interventional study of Co-ArgI-PEG modified human arginase I in Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Immedica Pharma AB. Completed at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Immedica Pharma AB · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2017, 8 years 11 months ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in Oct 2018.
Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is the first study of the safety of increasing dose levels of AEB1102 in patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study will also evaluate the amounts of AEB1102 in blood, the effects of AEB1102 on blood amino acid levels and the antitumor effects of AEB1102.

Read the detailed description

First study of the safety of increasing dose levels of AEB1102 in patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study will also evaluate the amounts of AEB1102 in blood, the effects of AEB1102 on blood amino acid levels and the antitumor effects of AEB1102.

02

Conditions studied

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Keywords

  • AML
  • MDS
03

In context

Leukemia, Myeloid, Acute

2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.

This study's enrollment of 21 is below the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

Immedica Pharma AB is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Willing and able to provide informed consent
  • Age 18 and older
  • Diagnosis of AML or MDS according to the WHO criteria
  • AML relapsed or refractory to at least one attempt at induction or subjects not candidates for aggressive induction regimens
  • MDS refractory to treatment with HMA therapy or with recurrence or progression of MDS following a response to an HMA
  • Has adequate organ function: AST and ALT \< 3X the ULN, serum bilirubin \< 2X the ULN, serum creatinine of \< 2 mg/dL, or a calculated creatinine clearance of > 50 mL/minute
  • ECOG Performance Score of 0 -2
  • Recovered from the effects of any prior systemic therapy, radiotherapy or surgery
  • Willing to use physician approved birth control method

Exclusion criteria

Exclusion Criteria:

  • Current CNS Leukemia
  • Acute promyelocytic leukemia or AML with a t(15;17) (q22;q12) cytogenetic abnormality or Bcr/Abl positive leukemia
  • \< 60 days from ASCT; has chronic graft-versus host disease (GVHD) or requires continued treatment with systemic immunosuppressive agents
  • Uncontrolled infection
  • Known HIV, hepatitis B or hepatitis C.
  • Other active malignancy that requires therapy
  • If female, is lactating or breast feeding
  • Hypersensitivity to PEG or other component of AEB1102 (Co-ArgI-PEG)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    AEB1102 (Co-ArgI-PEG) administered via IV weekly.

    Co-ArgI-PEG modified human arginase I

    Drug: Co-ArgI-PEG modified human arginase I

Interventions

  • DrugCo-ArgI-PEG modified human arginase I

    Also known as: AEB1102

06

What researchers measure

Primary outcomes

  1. Maximum Tolerated Dose and Recommended Phase 2 Dose

    The dose level at which no more than 1/6 patients experiences dose-limiting toxicity

    Time frame: 4 weeks

Secondary outcomes

  1. Safety profile (changes in physical exam, laboratory measures, reported adverse events)

    changes in physical exam, laboratory measures, reported adverse events

    Time frame: 4 Weeks

07

Study locations

10 sites
  • Comprehensive Cancer Center at University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Washington University Medical School
    St Louis, Missouri 63110, United States
  • University Hospitals Case Medical Center
    Cleveland, Ohio 44106, United States
  • The Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232, United States
  • Baylor Scott & White
    Dallas, Texas 75246, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
  • University of Alberta
    Edmonton, Alberta, Canada
  • Princess Margaret Cancer Centre
    Toronto, Ontario, Canada
  • Jewish General Hospital
    Montreal, Quebec, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02732184
Lead sponsor
Immedica Pharma AB
Collaborators
Aeglea Biotherapeutics (Study sponsor)
Responsible party
Sponsor
First posted
Apr 8, 2016
Start date
Aug 15, 2016
Primary completion
Nov 1, 2017
Completion
Nov 1, 2017
Last update
Aug 13, 2026

Study contacts

Mattias Rudebeck, PhD MSc BMedSc
study director · Immedica Pharma AB

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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