A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-504 in Patients With Advanced Solid Tumors
This is a Phase I, first-in-human, open-label, dose-escalation study of Volitinib (HMPL-504)
administered orally once every day(QD) to patients with locally advanced or metastatic solid
tumors.There are two stages to this study : a dose-escalation stage and a dose-expansion
stage. The dose-escalation stage is designed to evaluate the safety, tolerability, and
pharmacokinetics of single dose and repeat doses of HMPL-504 given once every day (QD). An
alternative dosing schedule of twice every day (BID) may be investigated if pharmacokinetic
studies indicate faster than anticipated clearance of HMPL-504.
All patients will be carefully followed for adverse events during the study treatment and
for 30 days after the last dose of study drug. Subjects of this study will be permitted to
continue therapy with only safety monitoring and bimonthly assessments for progression, if
the product is well tolerated and the subject has stable disease or better.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The safety and tolerability of single and multiple doses of HMPL-504 administered to patients.
The primary endpoint is evaluation of safety and tolerability during all the study of therapy following the initiation of multiple dosing of HMPL-504. The safety and tolerability variables to be evaluated in this study are adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology(Maximum Tolerated Dose) , and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for protein), and electrocardiograms (ECGs) in triplicate,Incidence and nature of DLTs(Dose-Limiting Toxicity),To determine the MTD (Maximum Tolerated Dose).
up to 20 months
Michael Millward, MD,Ph.D
Sir Charles Gairdner Hospital & University of WA
Australia: Department of Health and Ageing Therapeutic Goods Administration