A Study of HMPL-453 in Patients With Advanced Solid Malignancies
Status:
Active, not recruiting
Trial end date:
2020-06-30
Target enrollment:
Participant gender:
Summary
This is a dose escalation study consisting of two stages: Dose-escalation stage (stage 1):
Patients will take a single dose of HMPL-453 on Day 1 and will be followed for one week for
safety observations. After one week of observation, if no safety issues occur, patients can
continue multiple dosing of HMPL-453 QD (quaque die) and start on the DLT (Dose Limited
Toxicity) assessment cycles. Each cycle consists of 28-days. Patients are required to draw
blood samples for PK and safety analysis at specific time points during the treatment;
Dose-Expansion Stage (Stage 2): This stage is to further evaluate the safety, tolerability,
PD (pharmacodynamics) profile, and preliminary anti-tumor activity of HMPL-453 at the RP2D
(recommended phase 2 dose) in approximately 10 patients with advanced solid tumor.