drugset / Trial / NCT03243643

Tolerability, Safety, Pharmacokinetics and Efficacy of HS-10241 Single Agent or Combined With Apatinib in Patients With Advanced Solid Tumors

NCT03243643

Phase 1 Unknown 80 enrolled Jiangsu Hansoh Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelOther

Summary

To investigate tolerability, safety, pharmacokinetics and efficacy of C-met Kinase Inhibitor HS-10241 single agent or combined with Apatinib in Subjects With Advanced Solid Tumours that are not eligible for conventional or intensive treatment. The dose of HS-10241 will be escalated to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of HS-10241 single agent and in combination with Apatinib in advanced cancer patients. At the same time, pharmacokinetic characteristics and preliminary efficacy of HS-10241 or combined with Apatinb will be observed in advanced cancer patients. To determine the recommended dosage regimen for phase II.

Timeline

Start
2017-08-08
Primary completion
2019-07
Completion
2019-12

Drugs

EvaluationDrugModalityDoseRoute
Subject HS-10241 Small molecule 200 mg Oral
Subject HS-10241 Small molecule 1200 mg Oral
Subject Rivoceranib Small molecule 500 mg Oral