At a glance
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Phase I/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of JSKN003 in Chinese Subjects With Advanced Solid Tumors
In Brief
A Phase 2 clinical trial evaluating JSKN003 for Advanced Solid Tumor. Active but no longer recruiting, targeting 725 participants across 34 sites.
Detailed 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.
Study Details
Timeline
Interventions
JSKN003 should be administered intravenously on the first day of each 3-week cycle.