Hutchison China MediTech (Chi-Med) has initiated a Phase I study of HMPL-523. It is the company’s novel spleen tyrosine kinase inhibitor, along with azacitidine, which is an approved nucleoside metabolic inhibitor in elderly patients with acute myeloid leukaemia in China.
This is a two-stage study with dose escalation and dose expansion. Phase I is an open-label, non-randomised, multi-centre study. The primary outcome measures are overall response rate (ORR) and adverse events (AE). This study complements the ongoing Phase Ib dose expansion programme of HMPL-523 in a broad range of hematological cancers in Australia and China. The company plans to present the dose escalation results at a major scientific conference in 2018 or 2019.
Additional details about this study may be found at clinicaltrials.gov using identifier NCT03483948.