drugset / Trial / NCT05278728

Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer

NCT05278728

Phase 1/2 Completed 31 enrolled Biotech Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.

Timeline

Start
2009-07
Primary completion
2013-08
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 180 mg/m2
Subject Nimotuzumab Monoclonal antibody 200 mg
Subject Nimotuzumab Monoclonal antibody 400 mg
Subject Nimotuzumab Monoclonal antibody 600 mg
Subject Nimotuzumab Monoclonal antibody 800 mg

Indications