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.
Be able to understand informed consent form, voluntarily participate and sign informed consent form.
Age ≥18 year (at the time consent is obtained), male or female.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Has a Life expectancy ≥3 months.
Has clinically active brain metastases.
Previously received any other investigational drug within 28 days prior to enrollment.
Previously received local palliative treatment within 14 days prior to enrollment.
Previously received major surgeries within 28 days prior to enrollment.
Single group
JSKN033
DrugJSKN033 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.
Maximum Tolerated Dose (MTD) or recommend Phase II dose (RP2D).
Based on safety and efficacy data.
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.
Anti-drug antibodies (ADA) and neutralizing antibodies
Status (positive or negative) and serum titers of anti-JSKN033 antibody.
Objective response rate (ORR)
ORR is determined by investigators based on RECIST 1.1 criteria.
Disease control rate (DCR)
DCR is determined by investigators based on RECIST 1.1 criteria.
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.
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This trial is not recruiting at the moment. You can still explore other options:
