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This is a phase I/II multicenter study to evaluate the safety and efficacy of JSKN033 in Chinese subjects with unresectable locally advanced/metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JSKN033 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JSKN033 | Drug | JSKN033 should be administered subcutaneously on the first day of each week cycle/ each 2-week cycle |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Incidence of DLT in the dose escalation period. | Up to 12 months |
| Maximum Tolerated Dose (MTD) or recommend Phase II dose (RP2D). | Based on safety and efficacy data. | Up to 12 months |
| Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAE) and Treatment Related Adverse Events (TRAE) | TEAE and TRAE were graded according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0. | Throughout the duration of the study, approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-drug antibodies (ADA) and neutralizing antibodies | Status (positive or negative) and serum titers of anti-JSKN033 antibody. | Throughout the duration of the study, about 2 years |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XiaoHua Wu, MD | Contact | 02134778299 | wu.xh@fudan.edu.cn | |
| Jian Zhang, MD | Contact | 02134778299 | syner2000@163.com |
| Name | Affiliation | Role |
|---|---|---|
| XiaoHua Wu, MD | Fudan University | Principal Investigator |
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ORR is determined by investigators based on RECIST 1.1 criteria.
| Throughout the duration of the study, about 2 years |
| Disease control rate (DCR) | DCR is determined by investigators based on RECIST 1.1 criteria. | Throughout the duration of the study, about 2 years |
| Progression-free survival (PFS) | PFS is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic disease progression or death due to any cause. | Throughout the duration of the study, about 2 years |
| Maximum concentration (Cmax) | Categories: JSKN003, total antibody (Tab) , payload of JSKN003 and envafolimab. | Throughout the duration of the study, about 2 years |
| Time at which Cmax is reached (Tmax) | Categories: JSKN003, total antibody (Tab) , payload of JSKN003 and envafolimab. | Throughout the duration of the study, about 2 years |
| Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast) | Categories: JSKN003, total antibody (Tab) , payload of JSKN003 and envafolimab. | Throughout the duration of the study, about 2 years |