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This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 in subjects with advanced cancers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3002 Tablets | Experimental | TQB3002 Tablets, 28 days as a treatment cycle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3002 Tablets | Drug | TQB3002 is a fourth-generation small molecule Epidermal growth factor receptor (EGFR) inhibitor, which inhibits relevant tyrosine kinase activity and intracellular phosphorylation process by competitively binding to Adenosine triphosphate (ATP) site of intracellular tyrosine kinase binding domain, thereby inhibiting EGFR downstream signaling, ultimately achieving the purpose of inhibiting tumor growth. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(28days) of treatment. | During the first 28 days |
| Maximum tolerated dose (MTD) | MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients. | During the first 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Half-life (T1/2) | Terminal half-life (T1/2) | Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration |
| The area under the curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Zhou, Doctor | Contact | 020-83827812 | zhouqing@gdph.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510180 | China |
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The area under the curve (AUC) of serum concentration of TQB3002
| Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration |
| Apparent Plasma Clearance (CL) | Apparent plasma clearance of TQB3002 | Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration |
| Apparent volume of distribution (Vz) | The ratio of the amount of TQB3002 in the body to the blood concentration | Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration |
| Minimum concentration (Cmin) | Minimum observed concentration (Cmin) of TQB3002 | Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration |
| Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center | Not yet recruiting | Shenzhen | Guangdong | 518117 | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
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| Jiangsu Province Hospital | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
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| The First Affiliated Hospital Of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330038 | China |
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| Shanghai Pulmonary Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi’an | Shanxi | 710004 | China |
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| The First Affiliated Hospital of Xi'an Jiao Tong University | Not yet recruiting | Xi’an | Shanxi | 710061 | China |
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| Sichuan Cancer Hospital | Not yet recruiting | Chengdu | Sichuan | 610040 | China |
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| Mianyang Central Hospital | Not yet recruiting | Mianyang | Sichuan | 621099 | China |
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| Yunnan Cancer Hospital | Not yet recruiting | Kunming | Yunnan | 650118 | China |
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