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Based on the differentiated R&D strategy, the sponsor applies for the termination of the project.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KN052 single drug group | Experimental | The 8 dose groups in the dose increasing period were intravenous administration of 0.01mg/kg, 0.1mg/kg, 0.3mg/kg, 1mg/kg, 2mg/kg, 4mg/kg, 6mg/kg and 9mg/kg every two weeks, respectively. Based on the selected maximum tolerated dose of Q2W and in combination with the pharmacokinetic model, the sponsor would consider adding 1-2 Q3W treatment groups, with 6-12 patients in each dose group for DLT observation to explore the optimal dose regimen. The queue extension period is dose RP2D; Give it intravenously every two weeks or three weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KN052 | Biological | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 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 | Throughout the duration of the study,About 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The probability of adverse events | Including the occurrence probability of TESAE, TEAE, TRAE, irAE, IRR and AE above grade CTCAE 3 | Throughout the duration of the study,About 1 year |
| Frequency of interruption, delay, and termination of dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
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The frequency of interrupted, delayed, and discontinued dosing was statistically analyzed by treatment dose group/cohort (tumor type)
| Throughout the duration of the study,About 1 year |
| Frequency of immunogenicity | Frequency of occurrence of anti-KN052 antibody and neutralizing antibody | Throughout the duration of the study,About 1 year |
| Cmax of KN052 | Maximum observed serum concentration of KN052 | Throughout the duration of the study,About 1 year |
| Tmax of KN052 | Time of Maximum observed serum concentration (Tmax) of KN052 | 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 | Throughout the duration of the study,About 1 year |