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This is a Phase I clinical study aimed at evaluating the safety and pharmacokinetics of TQB2922 subcutaneous injection in patients with advanced cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2922 injection (subcutaneous injection) | Experimental | TQB2922 injection (Subcutaneous Injection), 28 days as a treatment cycle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2922 injection (subcutaneous injection) | Drug | TQB2922 is a bispecific antibody against Epidermal Growth Factor Receptor (EGFR)/c-Met. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Peak Concentration | Time to Peak Concentration | Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days) |
| Peak concentration | Maximum plasma drug concentration | Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days) |
| half-life (T1/2) | Terminal half-life (T1/2) | Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days) |
| The area under the curve (AUC0-∞) | The area under the plasma concentration-time curve extrapolated from the first administration to infinity | Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days) |
| The area under the curve (AUC0-t) | The area under the plasma concentration-time curve from the time of the first administration to the last quantifiable concentration time point. | Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) rate | The occurrence and severity of all AEs | From date of the first dose until the date of 30 days after last dose or new anti-tumor treatment, whichever came first |
| Objective Response Rate (ORR) |
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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 |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Elimination Rate | Reflects the rate at which a drug disappears from the bloodstream | Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days) |
| Apparent Oral Clearance | The mixed effect reflecting the drug's clearance ability and absorption degree. | Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days) |
| Apparent Volume of Distribution | The mixed effect reflecting the degree of drug distribution and absorption. | Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days) |
| Trough Concentration | The blood drug concentration at the moment before the next administration. | Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days) |
| Accumulation Ratio | The ratio of the drug exposure at a steady state to the drug exposure after the first administration. | Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days) |
Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria
| Up to 2 years |
| Duration of Response (DOR) | Defined as the time from first documented response to documented disease progression. | Up to 3 years |
| Progression-free survival (PFS) | Defined as the time from the first dose of TQB2922 to the first occurrence of disease progression or death from any cause. | Up to 3 years |
| Incidence of anti-drug antibody (ADA) | Incidence of anti-drug antibody (ADA) | From the time of informed consent signed through 90 days after the last dose. |
| Henan Cancer Hospital | 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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| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410013 | China |
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| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
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| Affiliated Zhongshan Hospital of Dalian University | Recruiting | Dalian | Liaoning | 116001 | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
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| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| West China hospital, Sichuan University | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
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| Chengdu Third People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610100 | China |
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| ID | Term |
|---|---|
| D007279 | Injections, Subcutaneous |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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