Date: 2015-12-15
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Boehringer Ingelheim (Germany)
Product: BI 836858 in combination with decitabine
Action
mechanism: monoclonal antibody. BI 836858 is an anti-CD33 monoclonal antibody. Upon administration, anti-CD33 monoclonal antibody BI 836858 induces an antibody-dependent cellular cytotoxicity (ADCC) against CD33-expressing tumor cells, leading to cell death. CD33 is a cell adhesion molecule found only on the surface of haematopoietic cells, primarily cells of myeloid lineage, including monocytes, granulocytes and dendritic cells but is absent on haematopoietic stem cells. High CD33 expression is seen on malignant cells in acute myeloid leukemia (AML), which makes CD33 an ideal therapeutic target for the treatment of AML. Preclinical studies with this fully human IgG1 mAb have shown NK-mediated ADCC against malignant CD33+ AML blast cells. BI 836858 is currently being investigated in Phase I/II trials for the treatment of myeloid malignancies, AML and myelodyplastic syndromes (MDS).
Disease: acute myeloid leukemia (AML)
Therapeutic area: Cancer - Oncology
Country: Germany, USA
Trial
details: This phase 1-2 trial is to determine the MTD and the recommended dose for Phase I Extension. Secondary objective is to investigate the safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine Phase I Extension: Primary objective is to collect additional data on safety, pharmacokinetics and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine. Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy. (NCT02632721 )
Latest
news: * On December 15, 2015, a Phase 2 trial sponsored by Boehringer Ingelheim was published on the NIH website ClinicalTrials.gov for BI 836858 and is currently recruiting participants.
