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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
430
JSKN033 should be administered subcutaneously on the first day of each week cycle/ each 2-week cycle
Dose-limiting toxicity (DLT)
Incidence of DLT in the dose escalation period.
Time frame: Up to 12 months
Maximum Tolerated Dose (MTD) or recommend Phase II dose (RP2D).
Based on safety and efficacy data.
Time frame: 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.
Time frame: Throughout the duration of the study, approximately 2 years
Anti-drug antibodies (ADA) and neutralizing antibodies
Status (positive or negative) and serum titers of anti-JSKN033 antibody.
Time frame: Throughout the duration of the study, about 2 years
Objective response rate (ORR)
ORR is determined by investigators based on RECIST 1.1 criteria.
Time frame: Throughout the duration of the study, about 2 years
Disease control rate (DCR)
DCR is determined by investigators based on RECIST 1.1 criteria.
Time frame: 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.
Time frame: Throughout the duration of the study, about 2 years
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Maximum concentration (Cmax)
Categories: JSKN003, total antibody (Tab) , payload of JSKN003 and envafolimab.
Time frame: 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.
Time frame: 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.
Time frame: Throughout the duration of the study, about 2 years