This is a open-label, multicenter, phase I study to evaluate tolerance and pharmacokinetics of TQB3454 tablets in subjects with advanced solid tumor or hematologic tumor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
96
TQB3454 tablets is a small molecule oral drug.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe Affiliated Hosptial of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGTianjing Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, China
Maximum 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
Cmax
Cmax is the maximum plasma concentration of TQB3454 or metabolite(s).
Time frame: Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose;
Tmax
To characterize the pharmacokinetics of TQB3454 by assessment of time to reach maximum plasma concentration.
Time frame: Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose;
AUC0-t
To characterize the pharmacokinetics of TQB3454 by assessment of area under the plasma concentration time curve from zero to infinity.
Time frame: Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose;
Objective response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: up to 60 weeks
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 60 weeks
2-hydroxyglutaric acid
Correlation between 2-hydroxyglutaric acid and efficacy
Time frame: Hour 0(pre-dose) on single dose; Hour 0(pre-dose) of day1, day8, day15, day28 on multiple dose of first cycle; hour 0(pre-dose) of day15, day28 of second and third cycle; hour 0(pre-dose) of day28 of fourth to eighth cycle.Each cycle is 28 days.
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Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
RECRUITINGThe First Affiliated Hosptial Zhejiang University School of Medical
Hangzhou, Zhejiang, China
RECRUITING