TQB3811 tablet is a second-generation tropomyosin receptor kinase (TRK) inhibitor that selectively inhibits the kinase activity of TRKA, TRKB, and TRKC, and also selectively inhibits the kinase activity of TRKA, TRKB, and TRKC that produce secondary drug-resistant mutations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
TQB3811 is a second-generation TrkA inhibitor.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGMaximum tolerated dose (MTD)
To evaluate MTD of TQB3811 tablets in Chinese adult patients with advanced solid tumors
Time frame: Baseline up to 32 weeks
Adverse events (AEs) and serious adverse events (SAEs)
The occurrence of all AEs and SAEs
Time frame: Baseline up to 28 days
Dose-limiting toxicity (DLT)
To evaluate DLT of TQB3811 tablets in Chinese adult patients with advanced solid tumors
Time frame: Baseline up to 32 weeks
Time to reach maximum (peak) plasma concentration following drug administration(Tmax)
To characterize the pharmacokinetics of TQB3811 by assessment of time to reach maximum plasma concentration after single and multiple dosing
Time frame: 15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Maximum (peak) plasma drug concentration (Cmax)
Cmax is the maximum plasma concentration of TQB3811 or metabolite(s).
Time frame: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1.
Elimination half-life (t1/2)
t1/2 is time it takes for the blood concentration of TQB3811 or metabolite(s) to drop by half.
Time frame: 15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
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Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
To characterize the pharmacokinetics of TQB3811 by assessment of area under the plasma concentration time curve from the first dose to infinity.
Time frame: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1.
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)
Cmax,ss is maximum (peak) steady-state plasma drug concentration during a dosage interval .
Time frame: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Minimum steady-state plasma drug concentration during a dosage interval (Css-min)
Css-min is minimum steady-state plasma drug concentration during a dosage interval.
Time frame: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Concentration at the end of the dosing interval (AUCtau,ss)
To characterize the pharmacokinetics of TQB3811 by assessment of area The concentration at the end of the administration interval
Time frame: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Progress Free Survival(PFS)
From the start of randomization to the first tumor progression or time of death.
Time frame: up to 96 weeks
Disease control rate(DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 96 weeks
Duration of Response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Time frame: up to 96 weeks