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TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a phase I study to evaluate the safety, tolerability and effectiveness of TQB102 injection in subjects with advanced malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2102 injection | Experimental | intravenous infuse TQB2102 injection every three weeks, 21 days as a treatment cycle. (1.5mg/kg, 3mg/kg, 4.5mg/kg, 6mg/kg, 7.5mg/kg, 9mg/kg) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2102 injection | Drug | TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against HER2, a enzyme-cleavable linker, and a topoisomerase I inhibitor payload. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | DLT was defined as toxicities that meet pre-defined severity criteria (according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle (21 days) of treatment. | During the first treatment cycle (21 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. | During the first treatment cycle (21 days). |
| The occurrence rate of all adverse events (AEs) | The occurrence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) | From date of the first dose until 28 days after last dose or new anti-tumor treatment, whichever came first. |
| Dose escalation: recommended phase 2 dose (RP2D) | The RP2D of DT-9081 is determined using pharmacokinetics, pharmacodynamics and safety data of the dose escalation part of the study. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Incidence of anti-drug antibody (ADA) | Before infusion on Cycle1 Day1, Cycle2 Day1, Cycle 4 Day1, Cycle7 Day1, Cycle12 Day1 (each cycle is 21 days). 90 days after the end of the last infusion. |
| Area under the curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital. | Fuzhou | Fujian | 350000 | China | ||
| Sun Yat-sen University Cancer Center |
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The area under the curve (AUC) of serum or plasma concentration of ADC drug, total antibody, and small molecule toxin.
| Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 days |
| Peak concentration (Cmax) | Maximum observed concentration (Cmax) of ADC drug, total antibody, and small molecule toxin. | Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4 hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 days |
| Terminal half-life (T1/2) | Terminal plasma half-life is the time required to divide the plasma concentration by two. | Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4 hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 day |
| 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 | Baseline up to 2 years. |
| Disease control rate (DCR) | Defined as the proportion of subjects with CR, PR, or SD (Stable Disease). | Baseline up to 2 years. |
| Duration of Response (DOR) | Defined as the time from first documented response to documented disease progression. | Baseline to the date of documented disease progression, up to 2 years. |
| Progression-free survival (PFS) | Defined as the time from first documented response to documented disease progression. | Baseline to the date of documented disease progression, up to 2 years. |
| Overall survival(OS) | Overall survival refers to the time from the first treatment to death from any cause. | Baseline to the date of death from any cause, up to 2 years. |
| Guangzhou |
| Guangdong |
| 510060 |
| China |
| Harbin Medical University Cancer Hospital, Harbin, China | Harbin | Heilongjiang | 150000 | China |
| The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410000 | China |
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210000 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 11000 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710000 | China |
| Fudan University shanghai Cancer Center | Shanghai | Shanghai Municipality | 200000 | China |
| Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology | Shanghai | Shanghai Municipality | 200092 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610000 | China |
| Mianyang Central Hospital | Mianyang | Sichuan | 621000 | China |