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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Advanced and/or Metastatic Solid Tumours

NCT number NCT00369252
Study type Interventional
Source YM BioSciences
Contact
Status Completed
Phase Phase 1
Start date June 2005

See also
  Status Clinical Trial Phase
Recruiting NCT04839991 - Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours. Phase 1
Active, not recruiting NCT05836623 - A Phase I Study to Assess PSMA+ and PSMA- Tumour Lesions Phase 1