Phase I Study of Nimotuzumab in Solid Tumours
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.
Advanced and/or Metastatic Solid Tumours
Drug: Nimotuzumab (TheraCIM h-R3)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of TheraCIM-hR3 (YMB1000) in Patients With Solid Tumours|
|Study Start Date:||June 2005|
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.
|Princess Margaret Hospital|
|Toronto, Ontario, Canada|
|Principal Investigator:||Eric Chen, MD||University Health Network, Toronto|
|Principal Investigator:||Lillian Siu, MD||University Health Network, Toronto|