JSKN016HC in Patients With Advanced or Metastatic Solid Malignant Tumors
brief summary
This is a Phase I, open-label, multicenter, first-in-human study to evaluate the safety, tolerability, PK/pharmacodynamic (PD) characteristics, and anti-tumor activity of JSKN016HC in subjects with advanced malignant solid tumors.
detailed description
JSKN016HC is a subcutaneously injectable formulation of a bispecific ADC targeting HER3 and TROP2 (the main active ingredient is JSKN016).
This study will use i3+3 design for dose escalation, with a total of 4-7 dose cohorts designed. The starting dose is 4 mg/kg, Q2W. The dose cohorts and observation periods are defined in the Dose Escalation Table. During the study, necessary adjustments to the escalation dose and dosing interval may be made based on the obtained safety, PK, and other results.
During dose escalation, the SMC will conduct continuous safety assessments. The safety data for each dose cohort must be reviewed and a decision must be made by the SMC before dosing of the next dose cohort can begin. For Dose Cohort 2 (5 mg/kg Q2W), Dose Cohort 4 (7 mg/kg Q2W), and Dose Cohort 6 (9 mg/kg Q2W), the SMC may decide whether to skip these dose cohorts based on a comprehensive consideration of prior safety, PK (if available), and other data.
official title
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/ Pharmacodynamics, and Anti-tumor Activity of JSKN016HC in Subjects With Advanced Malignant Solid Tumors