NCT00369252

Phase I Study of Nimotuzumab in Solid Tumours

A Phase I Study of TheraCIM-hR3 (YMB1000) in Patients With Solid Tumours

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (planned)
• Sponsor: YM BioSciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I trial of nimotuzumab that will be conducted in patients with advanced incurable solid tumors. This is a dose-seeking study to determine the maximum tolerated and recommended phase II doses of nimotuzumab that can be safely given to patients with advanced and/or metastatic solid tumors.

Detailed description

This is an open-label, dose-escalating, phase I trial of nimotuzumab in patients with advanced incurable solid tumors. The objective of this study is to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of nimotuzumab that can be given in a weekly schedule in patients with advanced and/or metastatic solid tumor cancer. This study will also examine the safety, pharmacodynamics and preliminary efficacy of nimotuzumab in this patient population.

Conditions

• Advanced and/or Metastatic Solid Tumours

Interventions

Type	Name	Description
DRUG	Nimotuzumab (TheraCIM h-R3)

Timeline

• Start date: 2005-06-01
• First posted: 2006-08-29
• Last updated: 2007-02-28

Locations

1 site across 1 country: Canada