TQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein. By binding to BCL-2 protein, TQB3909 releases Pro apoptotic proteins such as BCL-2-Anatagonist/Killer 1(BAK), BCL-2 associated X (BAX) protein and BCL-2 associated death (BAD) protein, promotes the release of cytochrome c from mitochondria, phosphatidylserine eversion, stimulates caspase 3 / 7 activity and caspase 3 / 9 cleavage, and induces apoptosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
126
TQB3909 is an inhibitor targeting BCL-2 protein
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
RECRUITINGInstitute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences &Peking Union Medical College
Tianjin, Tianjin Municipality, China
RECRUITINGDose-limiting toxicity(DLT)
DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Time frame: up to 18 months
Recommended Phase II Dose (RP2D)
DLT describes side effects of a drug or other treatment that are serious enough to To evaluate RP2D of TQB3909 tablets in adult patients with advanced solid tumors
Time frame: up to 18 months
Adverse events (AEs) and serious adverse events (SAEs)
The incidence and severity of AEs and SAEs, as well as abnormal laboratory test indicators.
Time frame: up to 18 months
Time to reach maximum(peak )plasma concentration following drug administration (Tmax)
To characterize the pharmacokinetics of TQB3909 by assessment of time to reach maximum plasma concentration after single and multiple dosing
Time frame: Within 32 weeks after administration
Maximum (peak) plasma drug concentration (Cmax)
Cmax is the maximum plasma concentration of TQB3909.
Time frame: Within 24 hours after administration
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Css-max)
Css-max is the steady state maximum concentration of TQB3909 .
Time frame: Within 32 weeks after administration
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
To characterize the pharmacokinetics of TQB3909 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.
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Time frame: Within 24 hours after administration
Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)
To characterize the pharmacokinetics of TQB3909 by assessment of area under the plasma concentration time curve from the first dose to infinity.
Time frame: Within 24 hours after administration
Area under the plasma concentration-time curve when reaching steady state (AUCss)
AUCss is the area under the curve of TQB3909.
Time frame: Within 32 weeks after administration
Apparent total clearance of the drug from plasma after oral administration (CL/F)
CL/F is total clearance rate for TQB3909.
Time frame: Within 24 hours after administration
Elimination half-life (t1/2)
t1/2 is time it takes for the blood concentration of TQB3909 to drop by half.
Time frame: Within 24 hours after administration
Mean residence time (MRT)
MRT describes the average time that TQB3909 remains in the body.
Time frame: Within 24 hours after administration
Minimum steady-state plasma drug concentration during a dosage interval (Css-min)
Css-min is the minimum plasma concentration of TQB3909.
Time frame: Within 32 weeks after administration
Degree of fluctuation(DF)
DF is the volatility coefficient of TQB3909.
Time frame: Within 32 weeks after administration
Average steady-state plasma drug concentration during multiple-dose administration (Css-av)
Css-av is the average of steady-state plasma concentration of TQB3909 .
Time frame: Within 32 weeks after administration
Apparent volume of distribution after non-intervenous administration (Vd/F)
Vd/F is the bioavailability corrected apparent distribution volume of TQB3909
Time frame: Within 24 hours after administration
Progression-free survival (PFS)
PFS is defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time frame: up to 18 months
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: up to 18 months
Complete response rate(CRR)
CRR refers to the percentage of patients who enter the clinical disappearance period of the disease after a certain treatment.
Time frame: up to 18 months
Disease control rate(DCR)
Percentage of participants achieving CR and PR and stable disease (SD).
Time frame: up to 18 months
Duration of Response (DOR)
The period from the participants first achieving CR or PR to disease progression.
Time frame: up to 18 months
Overall survival (OS)
OS is defined as the time from the first administration to all-cause death.
Time frame: up to 18 months
Protein concentration or gene expression level related to BCL-2 signaling pathway
To evaluate the changes of BCL-2 signaling pathway related to proteins or genes.
Time frame: up to 18 months