The purpose of this study is to assess the pharmacokinetics,safety and tolerability of Hemay020 and to determine the recommended dose for future Phase II study as well as to obtain preliminary information on the efficacy of Hemay020 in subjects with solid tumors. The study will be conducted in two parts. Part one, testing will be done on up to 16-31 subjects to determine the safety and tolerability of Hemay 020 in patients with advanced solid tumors. Part two, another 16-24 subjects with advanced or metastatic NSCLC, will be added to the trial to better define the tolerability and preliminary efficacy of Hemay020.
This is a phaseⅠsequential-group study of ascending single and multiple oral doses administered to subjects with advanced solid tumors. Each subject will receive a single dose of Hemay020, followed by a 2-week observation period, and then will receive Hemay020 administered once daily by mouth for 28 days. Each cycle consist of 28 days. Subjects will be enrolled in groups of 3 to 6. Depending on the safety and activity profile observed during the dose escalation phase, the dose selected for Part 2 may be adjusted. Part 2 is an extension part of two dose groups administered to subjects with NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Sun Yat-Sen University Cancer Centre
Guangzhou, Guangdong, China
Number of participants with adverse events
Time frame: At screening, weekly up to 18 months
Observed maximum concentration of Hemay020
Time frame: 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 hours post-dose on day 1 and day 42
Time of maximum concentration of Hemay020
Time frame: 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 hours post-dose on day 1 and day 42
Area under the plasma concentration versus time curve of Hemay020
Time frame: 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 hours post-dose on day 1 and day 42
Trough Plasma Concentrations of Hemay020
Time frame: 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 hours post-dose on day 1 and day 42
Predose plasma concentration
Time frame: Predose on day 8, 15, 22]
Disease control rate (complete response rate + partial response rate + stable disease rate) according to RECIST v1.1
Time frame: At screening, after 4 weeks of treatment
Objective response rate (complete response rate + partial response rate) according to RECIST v1.1
Time frame: At screening, after 4 weeks of treatment
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