Hutchison China MediTech (Chi-Med) has commenced a phase Ib/II proof-of-concept study in the US to evaluate its small molecule angio-immuno kinase inhibitor sulfatinib in pancreatic neuroendocrine tumors (NET) and biliary tract cancer (BTC).
The proof-of-concept study will assess the efficacy and safety of sulfatinib as a monotherapy in patients with advanced BTC, whose condition has progressed on standard first-line chemotherapy, and in patients with advanced pancreatic NET.
The primary and secondary endpoints of the phase Ib/II trial include progression-free survival (PFS) rate, objective response rate (ORR), disease control rate (DCR), duration of response (DoR), time to response, overall survival (OS), safety and tolerability.
Recently, a phase I dose escalation part of the study in the US was completed.
The phase Ib/II trial follows multiple trials of the drug that are currently in progress in China, including two phase III trials in pancreatic and non-pancreatic NET.
The two late-stage trials were started after positive results from a phase II study, and a phase II study in BTC patients, said Chi-Med.
Sulfatinib has been designed to selectively block the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and colony stimulating factor-1 receptor (CSF-1R). The three key tyrosine kinase receptors are known to be involved in tumor angiogenesis and immune evasion.
According to Chi-Med, Sulfatinib is the first oncology candidate it has taken through proof-of-concept in China and subsequently commenced clinical development in the US. Currently, the company is carrying out trials in six target patient populations on sulfatinib and has retained all the worldwide rights of the drug.
In China, the oral drug is in development as a monotherapy for patients with NET, thyroid cancer and BTC.
In January 2017, the company launched a phase II study in BTC patients in China. The phase II trial is a multi-center, single-arm, open-label study to assess the efficacy and safety of sulfatinib as a single agent in the treatment of advanced or metastatic BTC patients who failed one prior systemic therapy.