This is a phase Ia/Ib open, multicenter study of solid tumor subjects in China.Including dose increasing period and cohort expansion period.A BOIN design is used in the dose escalation phase,a total of 8 dose groups were designed.In the expansion phase of the cohort, 15 to 30 subjects will be enrolled in a specific tumor type (liver cancer, stomach cancer, kidney cancer, melanoma, urothelial carcinoma, and other tumors determined by the SMC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
0.01mg/kg, 0.1mg/kg, 0.3mg/kg, 1mg/kg, 2mg/kg, 4mg/kg, 6mg/kg, 9mg/kg, RP2D once every two or three weeks intravenously
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
MTD( Maximum tolerated Dose)
MTD (Maximum tolerated Dose) is the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate based on the BOIN Design
Time frame: Throughout the duration of the study,About 1 year
ORR(Objective Response Rate)
Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response \[CR\] or partial response \[PR\] per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Throughout the duration of the study,About 1 year
DOR(Duration Of Response)
Defined as the time from the first evaluation of objective response to the first evaluation of PD or death from any cause prior to PD
Time frame: Throughout the duration of the study,About 1 year
The probability of adverse events
Including the occurrence probability of TESAE, TEAE, TRAE, irAE, IRR and AE above grade CTCAE 3
Time frame: Throughout the duration of the study,About 1 year
Frequency of interruption, delay, and termination of dosing
The frequency of interrupted, delayed, and discontinued dosing was statistically analyzed by treatment dose group/cohort (tumor type)
Time frame: Throughout the duration of the study,About 1 year
Frequency of immunogenicity
Frequency of occurrence of anti-KN052 antibody and neutralizing antibody
Time frame: Throughout the duration of the study,About 1 year
Cmax of KN052
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Maximum observed serum concentration of KN052
Time frame: Throughout the duration of the study,About 1 year
Tmax of KN052
Time of Maximum observed serum concentration (Tmax) of KN052
Time frame: Throughout the duration of the study,About 1 year
AUC(0-T) for KN052
Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) for KN052
Time frame: Throughout the duration of the study,About 1 year