GPC Biotech, a German biopharmaceutical company, has opened enrollment in a Phase I study evaluating RGB-286638 in patients with advanced solid tumors. This is said to be the first time that this novel drug candidate is being studied in human clinical trials.
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The Phase I trial is an open label study being conducted at Erasmus University Medical Center, Rotterdam, The Netherlands under the direction of M de Jonge. The objectives of this study are to evaluate the safety and tolerability and to determine the maximum tolerated dose and recommended Phase II dose and schedule for RGB-286638 in patients with advanced solid tumors.
The trial is expected to enroll up to approximately 48 patients.
According to the company, the RGB-286638 compound has been shown in cancer cells to lead to the inhibition of cell cycle progression, the process that controls cell division and ensures the accurate duplication of genetic material, by targeting all relevant cyclin-dependent kinases, which are proteins involved in regulating the cell cycle.
Martine George, senior vice president of drug development and chief medical officer at GPC Biotech, said: We are excited to move RGB-286638 into clinical development. Dr de Jonge and her colleagues at Erasmus University are highly respected for their excellent work in cancer research, and we are pleased to have the opportunity to work with them.
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