The study will evaluate the safety and preliminary anti-tumor activity of Interleukin 21 (IL-21) in combination with Nexavar.
“Our preclinical data have demonstrated that IL-21 can be additive, or even synergistic, when used in combination with Nexavar and other tyrosine kinase inhibitors,” said Nicole Onetto, senior vice president and Chief Medical Officer of ZymoGenetics.
The phase I part of the study will establish the maximum tolerated dose of IL-21 given for one treatment course, consisting of two 5-day cycles of IL-21 in combination with a standard dose of Nexavar administered over a 6-week period. The phase II part of the study will evaluate the safety and preliminary anti-tumor activity of IL-21 at the dose established in phase I in combination with Nexavar.
Because tyrosine kinase inhibitors such as Nexavar inhibit the growth of tumor cells, and IL-21 activates the immune system to target killing of tumor cells, the two therapies may provide additive or synergistic effects.