The Phase I component enrolled patients at three centers in Canada and is evaluating the safety and feasibility of administrating nimotuzumab, a humanized monoclonal antibody that targets the epidermal growth factor receptor, at three dose levels (100mg, 200mg and 400mg weekly) with palliative radiation (30Gy in 10 fractions). The data will be used to select the optimal effective dose for the randomized Phase II component of the study, in which overall survival will be the primary endpoint.
Of the six patients enrolled in the first cohort (100mg), four partial response (PR) and two stable disease (SD) were reported. Median overall survival of the group was 41.5 weeks. All patients ultimately progressed. Two severe adverse events have been reported, neither causally attributable to nimotuzumab. A notable absence of grade III/IV rash or diarrhea in this cohort was reported.
Of the seven patients enrolled in the second cohort (200mg) of the study, two PR and five SD were reported. Median overall survival of the group has not been reached but currently exceeds 25 weeks. There has been a notable absence of grade III/IV rash or diarrhea reported in this cohort. Enrolment is now ongoing into the third cohort, to be treated at 400 mg per dose level, and accrual is anticipated to be completed by the end of 2007.
YM is conducting the trial in Canada and Kuhnil Pharmaceutical is conducting a parallel trial in Korea with a common protocol. This structure is designed to accelerate overall recruitment and lower the costs to the participants. The interim report from Phase I Korean patients is anticipated early in 2008.