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This study is a multicenter, single arm, and open design Phase I clinical trial aimed at evaluating the safety, Pharmacokinetics (PK) characteristics, immunogenicity, and preliminary efficacy of TQB2252 injection in subjects with advanced malignant tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2252 injection | Experimental | This product is administered via intravenous infusion, with recommended doses of 600mg TQB2223 monoclonal antibody and 200mg penpulimab injection, administered once every 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2252 injection | Drug | TQB2252 injection is a compound preparation of TQB2223 monoclonal antibody (LAG-3) and penpulimab (PD-1), with a specification of 300mg TQB2223 monoclonal antibody and 100mg (20ml) penpulimab per bottle. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AE) rate | The evaluation criteria for the nature and severity of adverse events are based on the National Cancer Institute's CommonTerminology Criteria for Adverse Events (NCI CTCAE version 5.0). | From date of the first dose until the date of 28 days after last dose or new anti-tumor treatment, whichever came first. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum observed plasma concentration (Tmax) | Time to reach maximum (peak) plasma concentration following drug administration | Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4~Cycle 8: pre-dose. (Each cycle is 21 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xing Zhang, Doctor | Contact | 13610223691 | zhangxing@sysucc.org.cn | |
| Qingqing Cai, Doctor | Contact | 13798101121 | caiqq@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong provincial people's hospital | Guangzhou | Guangdong | 519041 | China |
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| Maximum Plasma Concentration (Cmax) |
The Cmax is the maximum observed plasma concentration of TQB2252. |
| Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4~Cycle 8: pre-dose. (Each cycle is 21 days) |
| Elimination half-life (t1/2) | Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. | Day1 of Cycle1, Cycle3: within 30 minutes pre-dose, 0.25, 2, 4, 8, 24, 48, 168, 336 hour post dose. Day1 of Cycle2, Cycle4~Cycle 8: pre-dose. (Each cycle is 21 days) |
| Objective Response Rate (ORR) | 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 |
| Progression-free survival (PFS) | Defined as the time from the first dose of TQB2252 to the first occurrence of disease progression or death from any cause. | up to 2 years |
| Disease control rate (DCR) | Defined as the proportion of subjects with CR, PR, or Stable Disease (SD). | up to 2 years |
| Duration of Response (DOR) | Defined as the time from first documented response to documented disease progression. | up to 2 years |