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Can a modified enzyme starve Hard-to-Treat blood cancers?

NCT ID NCT02732184

Disease control Sponsor: Immedica Pharma AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This phase 1 trial is testing an investigational drug called AEB1102 in adults with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has returned or stopped responding to standard treatments. AEB1102 is a modified human enzyme that breaks down arginine, an amino acid that cancer cells may depend on to grow. The study aims to find the highest safe dose and to see how the drug affects blood amino acid levels and whether it has any anti-tumor effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AEB1102 (Co-ArgI-PEG), a modified human enzyme designed to break down arginine, an amino acid that cancer cells may need to grow.
What this could lead to
If AEB1102 proves safe and shows anti-cancer activity, it could become a new treatment option for patients with hard-to-treat AML or MDS who have run out of standard options.
What could go wrong
This is an early, small phase 1 trial focused on safety and dosing, so it is not yet known if AEB1102 will effectively fight the cancer. Possible side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

21 people

The number who actually took part.

Started

Aug 2016

Finished

Nov 2017

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * 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)

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia Myelodysplastic syndrome

Contacts and locations

Locations

  • Baylor Scott & White

    Dallas, Texas, 75246, United States

  • Comprehensive Cancer Center at University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Jewish General Hospital

    Montreal, Quebec, Canada

  • Princess Margaret Cancer Centre

    Toronto, Ontario, Canada

  • The Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alberta

    Edmonton, Alberta, Canada

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Washington University Medical School

    St Louis, Missouri, 63110, United States

More trials for these conditions

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