Date: 2015-11-18
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Astellas Pharma (Japan) Agensys (USA - CA)
Product: AGS67E
Action
mechanism: antibody drug conjugate. AGS67E is an antibody-drug conjugate that targets CD37 for the potential treatment of B/T-cell malignancies. AGS67E induces potent cytotoxicity, apoptosis, and cell-cycle alterations in many non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) cell lines and patient-derived samples in vitro. It also shows potent antitumor activity in NHL and CLL xenografts, including Rituxan-refractory models.
Disease: acute myeloid leukemia
Therapeutic area: Cancer - Oncology
Country: Canada, USA
Trial
details: The purpose of this study is to evaluate the safety and tolerability of AGS67E given at two dosing schedules (every three weeks or weekly), in subjects with acute myeloid leukemia (AML) and determine a safe dose for future development. In addition, this study will assess the pharmacokinetics (PK), the immunogenicity, and the antitumor activity of AGS67E. (NCT02610062)
Latest
news: * On November 18, 2015, a Phase I trial sponsored by Astellas was published on the NIH website ClinicalTrials.gov for AGS67E and is currently recruiting participants.
