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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ-B3101 | Experimental | TQ-B3101 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ-B3101 | Drug | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| The 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 | 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 | 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） | 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） | 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） |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | each 28 days up to intolerance the toxicity or PD (up to 24 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongming Pan, Doctor | Contact | 0571-86960497 | panhongming63@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310016 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37385995 | Derived | Lu S, Pan H, Wu L, Yao Y, He J, Wang Y, Wang X, Fang Y, Zhou Z, Wang X, Cai X, Yu Y, Ma Z, Min X, Yang Z, Cao L, Yang H, Shu Y, Zhuang W, Cang S, Fang J, Li K, Yu Z, Cui J, Zhang Y, Li M, Wen X, Zhang J, Li W, Shi J, Xu X, Zhong D, Wang T, Zhu J. Efficacy, safety and pharmacokinetics of Unecritinib (TQ-B3101) for patients with ROS1 positive advanced non-small cell lung cancer: a Phase I/II Trial. Signal Transduct Target Ther. 2023 Jun 30;8(1):249. doi: 10.1038/s41392-023-01454-z. |
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| 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):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） | 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） | up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |