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This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2922 for injection | Experimental | TQB2922 for injection, 28 days as a treatment cycle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2922 for injection | Drug | TQB2922 for injection is administrated to patients with advanced cancers, 28 days as a treatment cycle |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | DLT is defined as toxicities that meet pre-defined severity criteria according to the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5.0 toxicity assessment criteria, and assessed as having a suspected relationship to study drug that occurred. | During the first treatment cycle (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 treatment cycle (28 days). |
| Adverse events (AEs) rate | The occurrence rate of all AEs during treatment | From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first. |
| Adverse events (AEs) severity | The severity of all AEs occured during treatment | From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Half-life (T1/2) | Terminal half-life (T1/2) after administration | Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days. |
| The area under the curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhang, Doctor | Contact | 020-87343458 | zhangli@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing University Cancer Hospital | Not yet recruiting | Chongqing | Chongqing Municipality | 400030 | China |
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The area under the curve (AUC) of blood concentration-time of TQB2922. |
| Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days. |
| Apparent plasma clearance (CL) | Apparent plasma clearance of TQB2922. | Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days. |
| Apparent volume of distribution (Vz) | The ratio of the amount of TQB2922 in the body to the blood concentration | Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days. |
| Minimum concentration (Cmin) | Minimum observed concentration (Cmin) of TQB2922 | Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days. |
| Objective response rate (ORR) | The percentage of patients with complete response (CR) or partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. | Up to 2 years. |
| Duration of response (DOR) | The time from first documented response to documented disease progression. | Up to 2 years. |
| Progression-free survival (PFS) | The time from the first dose of TQB2922 to the first occurrence of disease progression or death from any cause. | Up to 2 years. |
| Immunogenicity of TQB2922 | Immunogenicity of TQB2922 is assessed according to the incidence of anti-drug antibody (ADA). | From the time of informed consent to 90 days after the last dose. |
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| The first affiliated hospital of Guangzhou medical university | Not yet recruiting | Guangzhou | Guangdong | 510062 | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150081 | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
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| Henan Provincine People's Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
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| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
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| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410011 | China |
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| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410013 | China |
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| Nanjing Drum Tower Hospital | Not yet recruiting | Nanjing | Jiangsu | 210008 | China |
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| Affiliated Zhongshan Hospital of Dalian University | Not yet recruiting | Dalian | Liaoming | 116001 | China |
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| Department of Medical Oncology, The First Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110001 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 7100614 | China |
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| Shanghai Pulmonary Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| Affiliated Hospital of North Sichuan Medical College | Not yet recruiting | Nanchong | Sichuan | 637000 | China |
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| Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| Yunnan Cancer Hospital | Not yet recruiting | Kunming | Yunnan | 650118 | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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