Hutchison China MediTech (Chi-Med) has commenced a Phase Ib/II trial to evaluate the efficacy and safety of sulfatinib as a monotherapy to treat patients with pancreatic neuroendocrine tumours (NET) and biliary tract cancer (BTC) in the US.

The proof-of-concept, multi-centre, single-arm, open-label trial seeks to enrol around 36 subjects.

The trial is expected to include patients with advanced BTC that have progressed on standard first-line chemotherapy, and patients with advanced pancreatic NET.

It will feature a dose-escalation phase and an expansion phase.

In the dose escalation phase, the trial intends to enrol 15 to 30 patients to provide five daily doses of sulfatinib at 50mg, 100mg, 200mg, 300mg and 400mg.

The expansion phase will be conducted to confirm the maximum tolerable dose (MTD) or the selected recommended Phase II dose (RP2D) from the dose escalation phase.

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It will also examine the observed toxicities, tolerability, and drug exposure levels.

“The trial is expected to include patients with advanced BTC that have progressed on standard first-line chemotherapy, and patients with advanced pancreatic NET.”

About six patients with advanced solid tumours are expected to be enrolled in this phase to further evaluate the safety, tolerability and pharmacokinetic (PK) characteristics to confirm the selected sulfatinib dose.

In addition, the participants will receive RP2D sulfatinib daily treatment continuously across a 28-day treatment cycle until disease progression, death, or intolerable toxicity at the investigator’s discretion for a favourable benefit to risk balance is reported.

The trials’ primary and secondary objectives 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.

Sulfatinib is currently under investigation as a single agent for patients with NET, thyroid cancer and BTC in China.

It is a new, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity of 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 involved in tumour angiogenesis and immune evasion.