A Multi-Center, Open-Label Study of Surufatinib (HMPL-012) in Patients With Advanced Solid Tumors

Summary

Primary Objective Dose Escalation: To evaluate the safety and tolerability of surufatinib in patients with advanced solid tumors and to determine the maximum tolerable dose (MTD) or recommended phase II dose (RP2D). Primary Objective Dose Expansion: To evaluate the anticancer activity of surufatinib in patients with advanced Biliary Tract Cancer (BTC), patients with advanced pancreatic neuroendocrine tumors (pNETs), patients with locally advanced, unresectable, metastatic extra-pancreatic neuroendocrine tumors (EP-NETs), and patients with soft tissue sarcomas (STS) treated at a dose of 300 mg QD. Secondary Objective: To evaluate the pharmacokinetic profile of multiple dose surufatinib in patients with advanced solid tumors and to evaluate the anti cancer activity of surufatinib in patients with advanced solid tumors.

Timeline

Start

2015-11

Primary completion

2023-04-25

Completion

2023-06-02

Publications

• Dasari A, Hamilton EP, Falchook GS, Wang JS, Li D, Sung MW, Chien C, Nanda S, Tucci C, Hahka-Kemppinen M, Paulson AS. A dose escalation/expansion study evaluating dose, safety, and efficacy of the novel tyrosine kinase inhibitor surufatinib, which inhibits VEGFR 1, 2, & 3, FGFR 1, and CSF1R, in US patients with neuroendocrine tumors. Invest New Drugs. 2023 Jun;41(3):421-430. doi: 10.1007/s10637-023-01359-2. Epub 2023 Apr 19.

Drugs

Indications