Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer

Sponsor
Biotech Pharmaceutical Co., Ltd.
Study ID
NCT05278728
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 31, 2009
Status verified
Feb 2025
Primary completion
Aug 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nimotuzumab and Irinotecan
    Nimotuzumab： 200, 400, 600 or 800mg weekly until progression or AEs Irinotecan：180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles

Primary Outcome Measure

The rate of grade 3/4 toxicity [ Time Frame: 3 months ]

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