Clinical Trial

Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors

Active, Not Recruiting Phase 1/2
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Record status
This record was last updated February 2, 2026 (before its estimated July 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is an open, multicenter study of phase I/II in Chinese subjects with unresectable locally advanced/metastatic solid tumors. It is divided into the dose escalation period and the cohort expansion period. A total of 8 dose groups (Q3W on the first day of intravenous administration) were designed in the dose escalation period. The initial dose was 1.0mg/kg administered Q3W, with a DLT observation period of 21 days. In the dose expansion phase, 7 cohorts were established.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-02-15; most recent amendment 2026-01-29.
Status change: Recruiting → Active, Not Recruiting 2025-09-12
Status change: Not Yet Recruiting → Recruiting 2023-07-14
Trial Details
NCT Number NCT05744427
Lead Sponsor Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Conditions Advanced Solid Tumor
Enrollment 725 participants
Start Date 2023-03-15
Primary Completion 2026-07-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-02