To study the pharmacokinetic characteristics of TQ-B3101 in the human body, recommend a reasonable regimen for subsequent research.
single arm, single or repeat dosing of TQ-B3101 on patients with solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Escalating doses of TQ-B3101 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 100 mg to 500 mg/day administered either once or twice a day. A treatment cycle is considered to be 28 days .
Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGThe maximum tolerated dose (MTD) of TQ-B3101
The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment
Time frame: 48 weeks
The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3101
Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug ：III °or above of non-hematological toxicity,IV°hematological toxicity ,Neutropenia associated with fever
Time frame: For 4 weeks for DLTs
Pharmacokinetics of TQ-B3101 (in whole blood):Peak Plasma Concentration(Cmax)
Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study of single-dose, full PK profiles will be obtained at H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28（D means Day）
Time frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Pharmacokinetics of TQ-B3101 (in whole blood):Peak time（Tmax）
Peak time（Tmax）,Tmax in h.In the study of single-dose, full PK profiles will be obtained at H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28（D means Day）
Time frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Pharmacokinetics of TQ-B3101 (in whole blood):Half life（t1/2）
Half life（t1/2）,t1/2 in h.In the study of single-dose, full PK profiles will be obtained at H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28（D means Day）
Time frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
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Pharmacokinetics of TQ-B3101 (in whole blood):Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study of single-dose, full PK profiles will be obtained at H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28（D means Day）
Time frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Pharmacokinetics of TQ-B3101 (in whole blood):Clearance（CL）
Clearance（CL）,CL in L/h.In the study of single-dose, full PK profiles will be obtained at H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28（D means Day）
Time frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Objective Response Rate(ORR)
Percentage of participants with OR based assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
Time frame: each 28 days up to intolerance the toxicity or PD (up to 24 months)