drugset
drugset / Trial / NCT02353143

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

NCT02353143 ↗

Phase 1 Terminated 71 enrolled Menarini Group
NaSequentialOpen-labelTreatment

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.

Timeline

Start
2014-12
Primary completion
2021-04-09
Completion
2021-04-09

Outcome

Outcome not reported

Stopped: “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.”

Drugs

EvaluationDrugModalityDoseRoute
Subject MEN1112 Monoclonal antibody 0.1 mg/kg Intravenous
Subject MEN1112 Monoclonal antibody 0.3 mg/kg Intravenous
Subject MEN1112 Monoclonal antibody 0.6 mg/kg Intravenous
Subject MEN1112 Monoclonal antibody 1 mg/kg Intravenous
Subject MEN1112 Monoclonal antibody 1.7 mg/kg Intravenous
Subject MEN1112 Monoclonal antibody 2 mg/kg Intravenous
Subject MEN1112 Monoclonal antibody 2.5 mg/kg Intravenous
Subject MEN1112 Monoclonal antibody 3 mg/kg Intravenous

Indications

acute myeloid leukemia