Hutchison MediPharma (HMP) has started a Phase I clinical trial of sulfatinib (HMPL-012) to treat patients with advanced solid tumours.
Earlier this year, the US Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for sulfatinib.
HMP is also planning two Phase III studies for neuroendocrine tumours (NET) and a Phase Ib trial in China for the treatment of thyroid cancer.
Taking place in the US, the Phase I dose escalation trial is designed to evaluate the safety and tolerability of sulfatinib.
A Phase II trial for NET is expected to begin after Phase I concludes.
Sulfatinib inhibits tyrosine kinase activity associated with the vascular endothelial growth factor receptor (VEGFR) and fibroblast growth receptor (FGFR). The latter is a receptor for a protein which plays a role in tumour growth.
In a Phase I trial in China, sulfatinib’s objective response rate among 18 NET patients was 44.4%.
Sunitinib and everolimus, the two approved single agent therapies for pancreatic NET, achieved objective response rates of less than 10% in their pivotal clinical trials.
In addition, NET responses to sulfatinib have been observed to improve gradually with time.
It is claimed that sulfatinib is HMP’s first oncology candidate to be taken through proof-of-concept in China, and expanded to a US clinical trial, without a partner.
Apart from the US Phase I trial, HMP is in the process of initiating four clinical trials in China.
Last October, the company started a multicentre, single-arm, open-label Phase Ib/II trial in broad spectrum NET patients in China.
This trial evaluated the efficacy, safety, tolerability, and pharmacokinetic characteristics of sulfatinib.
So far, the Phase Ib results appear in line with positive results from the Phase I trial.