Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia

• Status: Terminated
• Trial end date: 2021-04-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menarini Group
• Treatments: Antibodies, Monoclonal

Criteria

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).