Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:56 AM
Study NCT ID:
NCT07475559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
JSKN016HC in Patients With Advanced or Metastatic Solid Malignant Tumors
Sponsor:
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: