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TQB2618 is a TIM-3 receptor monoclonal antibody that binds to the extracellular domain of TIM-3 outside the cell to block the binding of TIM-3 to its ligand, thereby inhibiting the downstream signal transduction of TIM-3 and deactivating TIM-3 Inhibition of immune cells. The purpose of this study was to evaluate the safety, tolerability, pharmacokinetic parameters and antitumor effects of TQB2618 injection in subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2618 | Experimental | TQB2618 administered intravenously (IV) on Day 1 of each 21-day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2618 injection | Drug | TQB2618 administered intravenously (IV) on Day 1 of each 21-day. The established dose of TQB2618 is diluted to 100 m with normal saline [0.9% (w/v) sodium chloride solution], and the infusion time is 60 ± 10 min. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT. | Baseline up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | To characterize the pharmacokinetics of TQB2618 by assessment of time to reach maximum plasma concentration. | Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun Fan, Doctor | Contact | 0571-88122510 | fanyun@zjcc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of The University of Chinese Academy of Sciences | Hangzhou | Zhejiang | 310022 | China |
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| Cmax |
Cmax is the maximum plasma concentration of TQB2618 or metabolite(s). |
| Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days. |
| t1/2 | t1/2 is time it takes for the blood concentration of TQB2618 injection or metabolite(s) to drop by half. | Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days. |
| AUC0-t | To characterize the pharmacokinetics of TQB2618 by assessment of area under the plasma concentration time curve from zero to infinity. | Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days. |
| Receptor occupation (RO) | Receptor occupation of TIM-3 after single and multiple doses | Pre-dose, 30 minutes, 4 hours, 8 hours, 24 hours, 48 hours, 144 hours, 312 hours post-dose on day 1 and day 43; Pre-dose, 30 minutes post-dose within the second, fourth, sixth and eighth cycles. Each cycle is 21 days. |
| Overall response rate (ORR) | Percentage of participants achieving complete response (CR) and partial response (PR). | Up to 48 weeks |
| Progression-free survival (PFS) | PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause. | Up to 48 weeks |
| Disease control rate(DCR) | Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD). | Up to 48 weeks |
| Duration of response (DOR) | DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment. | Up to 48 weeks |