Acute Myeloid LeukemiaPhase 1NCT02732184
A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS
A Phase 1 study testing Co-ArgI-PEG modified human arginase I in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Immedica Pharma AB at 10 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- What is being tested?
- Co-ArgI-PEG modified human arginase I
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 15 Aug 2016to 1 Nov 2017
- 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
- 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
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- 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
Who cannot join
- 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)
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
Comprehensive Cancer Center at University of Michigan
Ann Arbor, Michigan, 48109
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
The Cleveland Clinic
Cleveland, Ohio, 44195
Baylor Scott & White
Dallas, Texas, 75246
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Washington University Medical School
St Louis, Missouri, 63110
Canada3 sites
University of Alberta
Edmonton, Alberta
Jewish General Hospital
Montreal, Quebec
Princess Margaret Cancer Centre
Toronto, Ontario
About this study
Official title: A Phase 1 Dose-Escalation Study of AEB1102 (Co-ArgI-PEG) in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Refractory to Hypomethylating Agents
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.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Being tested
- Co-ArgI-PEG modified human arginase I
- Keywords
- AML, MDS
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-ArgI-PEG modified human arginase IDrug
Also called AEB1102
| Study group | Role | What they receive |
|---|---|---|
| AEB1102 (Co-ArgI-PEG) administered via IV weekly. | Experimental | Co-ArgI-PEG modified human arginase I Receives: Drug: Co-ArgI-PEG modified human arginase I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose and Recommended Phase 2 Dose
The dose level at which no more than 1/6 patients experiences dose-limiting toxicity
Measured: 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
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study start15 Aug 2016
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immedica Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aeglea Biotherapeutics
- Responsible party
- Sponsor
- Investigators
- Mattias Rudebeck, PhD MSc BMedSc, Study director, Immedica Pharma AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732184
- Sponsor's protocol ID
- CAEB1102-100C
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2016
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Study of AEB1102 (Co-ArgI-PEG) in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Refractory to Hypomethylating Agents
- ClinicalTrials.gov ID
- NCT02732184
- Acronym / sponsor ID
- CAEB1102-100C
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Keywords
- AML, MDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Immedica Pharma ABIndustry (pharma, biotech, devices)
- Collaborators
- Aeglea Biotherapeutics
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 8 Apr 2016 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AEB1102 (Co-ArgI-PEG) administered via IV weekly. | Experimental | Drug: Co-ArgI-PEG modified human arginase ICo-ArgI-PEG modified human arginase I |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Co-ArgI-PEG modified human arginase IAlso: AEB1102 | Drug | AEB1102 (Co-ArgI-PEG) administered via IV weekly. |
Primary outcome
Maximum Tolerated Dose and Recommended Phase 2 Dose
Time frame: 4 weeks
The dose level at which no more than 1/6 patients experiences dose-limiting toxicity
1 secondary outcome
Safety profile (changes in physical exam, laboratory measures, reported adverse events)
Time frame: 4 Weeks
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 13 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Mattias Rudebeck, PhD MSc BMedSc study director
Immedica Pharma AB
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Co-ArgI-PEG modified human arginase I in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Immedica Pharma AB at 10 sites in 2 countries.
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 9 inclusion and 8 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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?
Maximum Tolerated Dose and Recommended Phase 2 Dose (time frame: 4 weeks). 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 13 Aug 2026.