This study is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects with Advanced Malignant Solid Tumour. Patients will be enrolled in two stages: a dose-escalation stage and a dose expansion stage.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
374
JS212 for Injection is administered on the first day of the first cycle and every 3 weeks thereafter.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGDLT
Incidence and severity of DLT events
Time frame: Up to 1 years
Incidence and severity of Adverse Events
Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.
Time frame: Up to 2 years
MTD
Maximum tolerated dose
Time frame: Up to 1 years
RP2D
Recommended phase II dose
Time frame: Up to 1 years
ORR
Objective Response Rate (ORR) as Assessed by Investigator according to RECIST v1.1
Time frame: Up to 2 years
DOR
Duration of Objective Response (DOR) as Assessed by Investigator according to RECIST v1.1
Time frame: Up to 2 years
DCR
Investigator-assessed Duration of objective Response (DCR) according to RECIST v1.1
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) as Determined by Investigator according to RECIST v1.1
Time frame: Up to 2 years
Overall Survival (OS)
Overall Survival (OS)
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Time frame: Up to 2 years
Pharmacokinetic (PK)
Patient blood concentrations and pharmacokinetic parameters after drug administration
Time frame: About 6 months after first dosing
Immunogenicity
Incidence of antidrug antibodies (ADA)
Time frame: About 6 months after first dosing