drugset
drugset / Trial / NCT05494918

First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors

NCT05494918 ↗

Phase 1 Completed 62 enrolled Alphamab (Australia) Co Pty Ltd.
NaSequentialOpen-labelTreatment

Summary

This study is an open-label, multicenter, first-in-human, Phase I, dose escalation study to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of JSKN003 in subjects with advanced inoperable or metastatic solid malignant tumors that are expected to be HER2 expression.

Timeline

Start
2022-09-02
Primary completion
2025-04-15
Completion
2025-04-15

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 5.3 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 9.4 mg/kg Intravenous
Subject JSKN003 Monoclonal antibody 10.5 mg/kg Intravenous

Indications

cancer metastatic neoplasm