Date: 2016-06-30
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Astellas Pharma (Japan) Agensys (USA - CA)
Product: AGS62P1
Action
mechanism: antibody drug conjugate. Here, we report the preclinical assessment of a novel FLT3 targeting ADC, AGS62P1. AGS62P1 consists of a human anti-FLT3 monoclonal antibody, site specifically conjugated to a potent cytotoxic payload. FLT3 expression is confirmed in a large panel of AML and ALL tumor cells as well as in AML patient specimens via flow cytometry. The anti-leukemic activity of AGS62P1 was evaluated against AML and ALL tumor cell lines, in vitro and in vivo.
Disease: acute myeloid leukemia
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The purpose of this study is to evaluate the safety and tolerability of AGS62P1 given at two dosing schedules (Schedule A, every three weeks or Schedule B, weekly), in subjects with acute myeloid leukemia (AML) and determine the maximum tolerated dose (MTD). In addition, this study will assess the pharmacokinetics (PK), the immunogenicity and the anti-leukemic activity of AGS62P1. ( NCT02864290)
Latest
news: * On June 30, 2016, a Phase I trial sponsored by Astellas was published on the NIH website ClinicalTrials.gov for AGS62P1 and is currently recruiting participants.
