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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China
Maximum tolerated dose (MTD)
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
Time frame: Baseline up to 28 days
Tmax
To characterize the pharmacokinetics of TQB2618 by assessment of time to reach maximum plasma concentration.
Time frame: 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.
Cmax
Cmax is the maximum plasma concentration of TQB2618 or metabolite(s).
Time frame: 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.
Time frame: 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.
Time frame: 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
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Time frame: 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).
Time frame: 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.
Time frame: Up to 48 weeks
Disease control rate(DCR)
Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Time frame: 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.
Time frame: Up to 48 weeks