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news.Munich-based drugmaker GPC Biotech has received clearance from Germany's health authorities to initiate human clinical testing with its investigational anticancer monoclonal antibody.
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The study is an open label, phase I trial evaluating 1D09C3 in patients with relapsed or refractory B-cell tumors who have failed prior standard therapy, and is using a different dosing regimen from the phase I study currently underway in Switzerland and Italy.
The goal of the trial is to determine the safety and tolerability of the antibody in patients and to recommend a dose and schedule for subsequent phase II studies. This second phase I study will be conducted at the University Hospital of Cologne under the direction of Professor Michael Hallek.
“Despite the progress made in treating lymphoid cancers, there remains a major unmet medical need for therapies to treat patients who have relapsed or become resistant to other treatments,” said Dr Marcel Rozencweig, senior vice president of drug development at GPC Biotech. “1D09C3 appears to have a different mechanism of action than the products currently used against these hematological cancers and, therefore, holds the potential to become an important new therapy in this area.”