A Multi-Center, Open-Label Study of Surufatinib (HMPL-012) in Patients With Advanced Solid Tumors
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
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.