HS-10342 is a small molecular, oral potent, selective CDK4/6 inhibitor. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic profile of HS-10342 in Chinese advanced solid tumor patients. Preliminary efficacy will be also investigated in this study.
This is a phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10342 in patients with advanced solid tumor by using a "3+3" dose escalation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
HS-10342 either 25mg, 50mg, 100mg, 150mg, 200mg given orally, QD or 50mg, 100mg, 150mg, 200mg, 250mg, 275mg given orally, BID
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Hospital
Guangzhou, Guangdong, China
Second Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Dose-Limiting Toxicity and Maximum Tolerated Dose of HS-10342.
The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one out of three subjects experience a dose-limiting toxicity (DLT) within the 5 week after the first dose.
Time frame: 5 weeks
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Jiangsu Province Hospital
Nanjing, Jiangsu, China