Clinical trial · Interventional
A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS
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
NCT02732184CI-TRIAL-00121995completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Co-ArgI-PEG modified human arginase I | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AEB1102 (Co-ArgI-PEG) administered via IV weekly.
- description
- Co-ArgI-PEG modified human arginase I
- interventionNames
- Drug: Co-ArgI-PEG modified human arginase I
Primary outcomes (1)
- measure
- Maximum Tolerated Dose and Recommended Phase 2 Dose
- timeFrame
- 4 weeks
- description
- The dose level at which no more than 1/6 patients experiences dose-limiting toxicity
Secondary outcomes (1)
- measure
- Safety profile (changes in physical exam, laboratory measures, reported adverse events)
- timeFrame
- 4 Weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.