Clinical trial · Interventional
Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia
First in Man Study With MEN1112, a CD157 Targeted Monoclonal Antibody, in Relapsed or Refractory Acute Myeloid Leukemia.
NCT02353143CI-TRIAL-00079710ARMYterminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The Sponsor accepted the iDSMB recommendation to terminate the study due to evidence of unpredictable liver toxicity and meaningful target engagement not translating into any clinical objective response.
Summary
Brief summary (as posted)
The purpose of this study is to assess the safety of MEN1112, given as intravenous infusion, in patients with relapsed or refractory AML. Pharmacokinetics, clinical activity and potential immunogenicity of MEN1112 will be evaluated as well.
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, in Relapse | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Recurrent Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEN1112 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MEN1112
- description
- Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation
- interventionNames
- Drug: MEN1112
Primary outcomes (2)
- measure
- Dose Limiting Toxicity (DLT)
- timeFrame
- over 3 weeks after the first dose
- description
- Identification of DLT defined as an adverse event occurring during the first treatment cycle, judged to be related to MEN1112 and meeting any of the following criteria: * Grade 3 non-haematological toxicity lasting more than 7 days * Grade ≥ 4 non-haematological toxicity.
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- over 3 weeks after the first dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients aged ≥ 18 years. * Documented definitive diagnosis of AML (according to WHO criteria, 2008) that is relapsed/refractory to standard treatment, for which no standard therapy is available or the patient refuses standard therapy. * WBC count ≤ 10 x 109/L at Visit 1/Day 1; hydroxyurea is allowed to lower WBC count. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at Visit1/Day 1. * Life expectancy of at least 2 months. * Adequate renal and hepatic laboratory assessments: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤3.0 × ULN, unless considered due to leukemic organ involvement, Total Bilirubin ≤2.0 × ULN, Serum creatinine ≤2.0 × ULN. * Able to give written informed consent before any study related procedure Exclusion Criteria: * Acute promyelocytic leukaemia (French-American-British M3 classification). * Active central nervous system involvement. * Haematopoietic stem cell transplantation (HSCT) performed within 3 months prior to Screening Visit. * Active infection requiring intravenous antibiotics. * Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety or interfere with the patient's ability to comply with the study activities. * Anti-tumour therapy within 14 days of study Visit 1/Day 1, excluding hydroxyurea. * Prior participation in an investigational study (procedure or device) within 21 days of study Visit 1/Day 1. * Radiotherapy within 28 days prior to study Visit 1/Day 1 or scheduled along the study conduct. * Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). * Other active malignancies. History of malignancy in the last 12 months (except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast or non-melanoma skin cancer).
References
Publications (0)
Data not yet available
No reference posted for this study.