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Sponsors and Collaborators: |
YM BioSciences CIMYM BioSciences |
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Information provided by: | YM BioSciences |
ClinicalTrials.gov Identifier: | NCT00369252 |
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.
Condition | Intervention | Phase |
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Advanced and/or Metastatic Solid Tumours |
Drug: Nimotuzumab (TheraCIM h-R3) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study of TheraCIM-hR3 (YMB1000) in Patients With Solid Tumours |
Estimated Enrollment: | 18 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada |
Principal Investigator: | Eric Chen, MD | University Health Network, Toronto |
Principal Investigator: | Lillian Siu, MD | University Health Network, Toronto |
Study ID Numbers: | YMB1000-007 |
Study First Received: | August 25, 2006 |
Last Updated: | February 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00369252 |
Health Authority: | Canada: Health Canada; Canada: Ethics Review Committee |
Nimotuzumab TheraCIM H-R3 |
Solid tumours EGFR Monoclonal antibody |
Antibodies, Monoclonal Antibodies Immunoglobulins |