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Clinical Trials

Date: 2017-02-13

Type of information: Treatment of the first patient

phase: 1

Announcement: treatment of the first patient

Company: Hutchison China MediTech Limited (China)

Product: HMPL-453

Action mechanism:

tyrosine kinase inhibitor/FGFR inhibitor. HMPL-453 is a novel, highly selective and potent small molecule inhibitor targeting fibroblast growth factor receptor (FGFR). Activation of FGFR signaling pathways is central to several biological processes, including angiogenesis, tissue growth and repair. Given its complexity and critical role in a number of important physiological processes, aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis, as well as, conferring resistance to anti-tumor therapies.

Disease: solid tumors

Therapeutic area: Cancer - Oncology

Country: Australia

Trial details:

The trial is a first-time-in-human, phase I, open-label, dose-escalation study of HMPL-453 in patients with advanced or metastatic solid malignancies who have failed or are intolerable to standard therapies or for whom no standard therapies exist. There are preliminary two stages in this study: a dose-escalation stage (stage 1) and a dose-expansion stage (stage 2). (NCT02966171)

Latest news:

* On Februray 13, 2017, Hutchison China MediTech announced that it has initiated the first-in-human Phase I clinical trial of HMPL-453 in Australia.  The first drug dose was administered on February 14, 2017. The FIH dose-escalation trial aims to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of HMPL-453 in patients with advanced or metastatic solid malignancies, who have failed or are unable to tolerate standard therapies or for whom no standard therapies exist. This open-label study consists of two preliminary phases, a dose-escalation (stage 1) and a dose-expansion stage (stage 2).

 

Is general: Yes