drugset
drugset / Trial / NCT05744427

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

NCT05744427 ↗

Phase 1/2 Active not recruiting 725 enrolled Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2023-03-15
Primary completion
2026-07-30
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject JSKN003 Monoclonal antibody 1 mg/kg Intravenous
Subject JSKN003 Monoclonal antibody 2.1 mg/kg Intravenous
Subject JSKN003 Monoclonal antibody 4.2 mg/kg Intravenous
Subject JSKN003 Monoclonal antibody 5.2 mg/kg Intravenous
Subject JSKN003 Monoclonal antibody 6.3 mg/kg Intravenous
Subject JSKN003 Monoclonal antibody 7.3 mg/kg Intravenous
Subject JSKN003 Monoclonal antibody 8.4 mg/kg Intravenous
Subject JSKN003 Monoclonal antibody 10.5 mg/kg Intravenous

Indications

neoplasm