drugset / Trial / NCT01226030

Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors

NCT01226030 ↗

Phase 1 Unknown 24 enrolled Protgen Ltd
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.

Timeline

Start
2009-09
Primary completion
2011-04
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject M2ES Protein / enzyme biologic 7.5 mg Intravenous
Subject M2ES Protein / enzyme biologic 15 mg Intravenous
Subject M2ES Protein / enzyme biologic 30 mg Intravenous
Subject M2ES Protein / enzyme biologic 60 mg Intravenous

Indications