This is a Phase I, open-label, multi-center, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profiles, and the preliminary antitumor activity of JSKN021 in advanced malignant solid tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
199
JSKN021 administered intravenously at selected dose levels according to protocol
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGTumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITINGFrequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc (Safety and tolerability of JSKN021)
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc.; abnormalities in physical examinations, laboratory tests, electrocardiograms, and other safety measures.
Time frame: From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.
Dose-limiting toxicity (DLT)
Incidence of dose-limiting toxicity (DLT) in each dose group.
Time frame: 21 days from the first dose
Optimal biological dose (OBD) and/or recommended Phase Ⅱ dose (RP2D) of JSKN021.
Based on safety and efficacy data.
Time frame: Up to 24 months
Objective response rate (ORR)
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: Up to 24months
Duration of response (DoR)
Duration of response (DoR) assessed according to RECIST v1.1.
Time frame: Up to 24months
Disease control rate (DCR)
Disease control rate (DCR) assessed according to RECIST v1.1.
Time frame: Up to 24months
Progression-Free Survival (PFS)
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Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGHubei Cancer Hospital
Wuhan, Hubei, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGXuzhou Central Hospital
Xuzhou, Jiangsu, China
RECRUITINGAffiliated Hospital of Jining Medical College
Jining, Shandong, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGTianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGProgression-free survival (PFS) is defined as the time from the date of initial administration till the first documentation of disease progression or death due to any cause (whichever occurs first).
Time frame: Up to 24months
Overall survival(OS)
Overall Survival (OS) is defined as the time from the date of initial administration till death due to any cause.
Time frame: Up to 24months
Immunogenicity
Incidence and titer changes of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs, if applicable)
Time frame: Up to 24months
Maximum concentration (Cmax) of JSKN021
Maximum concentration (Cmax) of JSKN021
Time frame: Up to 24months
Time to maximum concentration (Tmax) of JSKN021
Time to maximum concentration (Tmax) of JSKN021
Time frame: Up to 24 months.
Trough concentration (Ctrough) of JSKN021
Trough concentration (Ctrough) of JSKN021
Time frame: Up to 24 months
Area under the concentration-time curve of JSKN021
Area under the concentration-time curve of JSKN021
Time frame: Up to 24 months
Volume of distribution (V) of JSKN021
Volume of distribution (V) of JSKN021
Time frame: Up to 24 months
Elimination half-life (t1/2) of JSKN021
Elimination half-life (t1/2) of JSKN021
Time frame: Up to 24 months
Clearance (CL) of JSKN021
Clearance (CL) of JSKN021
Time frame: Up to 24 months