NCT05278728

Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer

Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Biotech Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Nimotuzumab and Irinotecan will be administered to the patient until disease progression or development of toxicity preclude further treatment. Irinotecan will be administered once every 14 days, the dosage is 180mg/m2; Nimotuzumab treatment be divided 3 levels: 200mg/w, 400mg/w, 600mg/w, weekly. The patients'blood test and liver and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed and every 6 weeks, when the total result is the CR or PR, the result of the 6th and the 12th week should be compared.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Nimotuzumab	200,400,600 or 800mg weekly until progression or AEs
DRUG	Irinotecan	180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-08-01
• Completion: 2013-12-01
• First posted: 2022-03-14
• Last updated: 2025-02-07

Locations

2 sites across 1 country: China