This is a open-label, phase I study to evaluate tolerance and pharmacokinetics of TQB3728 tablets in subjects with advanced solid tumor or hematologic tumor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
TQB3728 tablets is a small molecule oral drug.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGMaximum tolerated dose (MTD)
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
Time frame: Baseline up to 28 days
Tmax
To characterize the pharmacokinetics of TQB3728 by assessment of time to reach maximum plasma concentration.
Time frame: 30minutes pre-dose on day 1and day 8;1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 24hour, 72hour post-dose on day 1 and day 8; 48hour, 96hour post-dose on day 1.
Cmax
Cmax is the maximum plasma concentration of TQB3738 or metabolite(s).
Time frame: 30minutes pre-dose on day 1and day 8;1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 24hour, 72hour post-dose on day 1 and day 8; 48hour, 96hour post-dose on day 1.
AUC0-t
To characterize the pharmacokinetics of TQB3728 by assessment of area under the plasma concentration time curve from zero to specific time or infinity.
Time frame: 30minutes pre-dose on day 1and day 8; 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 24hour, 72hour post-dose on day 1 and day 8; 48hour, 96hour post-dose on day 1.
Progression-free survival (PFS)
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Time frame: up to 48 weeks
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: up to 48 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.