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TQB2930 is an anti-HER2 (Human Epidermal Growth Factor Receptor 2) bispecific antibody that can simultaneously bind two epitopes of HER2, leading to a dual HER2 signal blockage. This is a phase I study to evaluate the safety, tolerability and effectiveness of TQB2930 injection in subjects with advanced malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2930 injection | Experimental | Drug:Weekly intravenous infusion of TQB2930 injection,21 days as a treatment cycle. (2.5mg/kg, 5mg/kg, 10mg/kg) Drug:Every two weeks intravenous infusion of TQB2930 injection , 28 days as a treatment cycle.(20mg/kg) Drug:Every three weeks intravenous infusion of TQB2930 injection, 21 days as a treatment cycle. (30mg/kg) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2930 injection | Drug | TQB2930 is an anti-HER2 bispecific antibody. |
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| 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 from the first dose to the end of the first treatment cycle. | At the end of Cycle 1 (each cycle is 21 or 28 days) |
| Maximum tolerated dose (MTD) | MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients. | At the end of Cycle 1 (each cycle is 21 or 28 days). |
| Adverse events (AE) rate | The occurrence and severity of all AEs | 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 |
|---|---|---|
| immunogenicity | Incidence of anti-drug antibody (ADA) | Cycle 1 Day 1, Cycle 2 Day1, Cycle 4 Day1, Cycle 7 Day1, Cycle 12 Day1: pre-dose and end of the infusion.(each cycle is 21 or 28 days) |
| Pharmacokinetics: The area under the curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruihua Xu, Doctor | Contact | 86-20-87343468 | ruihxu@163.com |
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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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The area under the curve (AUC) of serum concentration of TQB2930
| Cycle1Day1, Cycle1Day8, Cycle1Day815, Cycle2 Day1, Cycle2Day8, Cycle2Day15 and Cycle3Day1: pre-dose, Cycle1Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion. Cycle2Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion.(21 or 28 days each) |
| Pharmacokinetics:Peak concentration (Cmax) | Maximum observed concentration (Cmax) of TQB2930 | Cycle1Day1, Cycle1Day8, Cycle1Day815, Cycle2 Day1, Cycle2Day8, Cycle2Day15 and Cycle3Day1: pre-dose, Cycle1Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion. Cycle2Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion.21 or 28 days each |
| Pharmacokinetics: T1/2 | Terminal half-life (T1/2) | Cycle1Day1, Cycle1Day8, Cycle1Day815, Cycle2 Day1, Cycle2Day8, Cycle2Day15 and Cycle3Day1: pre-dose, Cycle1Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion. Cycle2Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion.21 or 28 days each |
| 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 | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks |
| Disease control rate (DCR) | Defined as the proportion of subjects with CR, PR, or SD (Stable Disease). | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks |
| Duration of Response (DOR) | Defined as the time from first documented response to documented disease progression. | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks |
| Progression-free survival (PFS) | Defined as the time from the first dose of TQB2928 to the first occurrence of disease progression or death from any cause. | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks |
| Overall survival(OS) | Overall survival refers to the time from the first treatment to death from any cause. | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks |