TQB3915 is a selective estrogen receptor covalent antagonist, by covalently binding to estrogen receptor, by changing the conformation of ERα, blocking intracellular signal transmission, thereby inhibiting the growth of tumor cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
TQB3915 binds to estrogen receptors through covalent bonds, and blocks intracellular signal transmission by changing the conformation of ERα, thereby inhibiting the growth of tumor cells.
Sun Yat-Sen University Cancer Canter
Guangzhou, Guangdong, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGFirst Affiliated Hospital with Nanjin Medical University (Jiangsu Province Hospital)
Nanjing, Jiangsu, China
RECRUITINGDose-limiting toxicity (DLT)
The following adverse events related to the trial drug occurred within 1 treatment cycle (34 days) of the subject's first dose
Time frame: up to 7 months
Maximum Tolerated Dose (MTD)
The MTD was the previous dose at which the following toxicities occurred
Time frame: up to 7 months
Recommended Phase II Dose (RP2D)
To evaluate RP2D of TQB3915 Tablets in patients with advanced malignant tumors
Time frame: up to 7 months
Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (TRAEs)
Incidence of all adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)
Time frame: up to 18 months
Time to reach maximum(peak )plasma concentration following drug administration (Tmax)
To characterize the pharmacokinetics of TQB3915 by assessment of time to reach maximum plasma concentration after single dosing
Time frame: up to 18 months
Maximum (peak) plasma drug concentration (Cmax)
Cmax is the maximum plasma concentration of TQB3915.
Time frame: up to 18 months
Elimination half-life (t1/2)
t1/2 is time it takes for the blood concentration of TQB3915 to drop by half.
Time frame: up to 18 months
Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)
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To characterize the pharmacokinetics of TQB3915 by assessment of area under the plasma concentration time curve from the first dose to infinity.
Time frame: up to 18 months
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
To characterize the pharmacokinetics of TQB3915 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.
Time frame: up to 18 months
Apparent total clearance of the drug from plasma after oral administration (CL/F)
CL/F is total clearance rate for TQB3915.
Time frame: up to 18 months
Apparent volume of distribution(Vz/F)
Vz/F is the apparent distribution volume of TQB3915.
Time frame: up to 18 months
Maximum (peak) steady-state plasma drug concentration during during multiple-dose administration (Css,max)
Css,max is the steady state maximum concentration of TQB3915 .
Time frame: up to 18 months
Degree of fluctuation(DF)
DF is the volatility coefficient of TQB3915
Time frame: up to 18 months
Minimum steady-state plasma drug concentration during a dosage interval (Css,min)
Css,min is the minimum plasma concentration of TQB3915
Time frame: up to 18 months
Mean steady state plasma concentrations during a dosage interval (Css-av)
Css-av is the mean steady state plasma concentrations of TQB3915
Time frame: up to 18 months
Area under the steady-state plasma concentration-time curve(AUC0-τ)
AUC0-τis the area under the steady-state plasma concentration-time curve of TQB3915
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
Disease control rate(DCR)
Percentage of participants achieving CR and PR and stable disease (SD).
Time frame: up to 18 months
Clinical benefit rate (CBR)
Percentage of subjects who achieved complete remission (CR), partial remission (PR) and stable disease (SD) for at least 24 weeks
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
Progression-free survival (PFS)
PFS is defined as the time from the first treatment to the first disease progression or death from any cause
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