The University of Virginia is conducting a clinical research study for adults ages 18 and over, who have cancers with a specific mutation and have locally advanced or metastatic solid tumors. The purpose of this study is to test an investigational drug called SPYK04 to find out if it’s safe and to understand the way your body processes SPYK04.
You were asked to participate in this study because you have been diagnosed with cancer and your cancer has a gene mutation called RAS. Genes are instructions that control the cells in your body. A mutation is a change in a gene that gives the body different instructions. The RAS gene is important because when there is a change in this gene then cancer can occur. To be in this study, your cancer must have a mutation of the RAS gene confirmed by a pre-screening test.
This study has two parts. You are being asked to participate in Part II.
If you are eligible to be in the study, you will get the study drug at the dose determined to be the safest from part I of the study. SPYK04 is a capsule that you take by mouth with water once a day. All study treatment visits will happen in cycles. Each cycle is 28 days long. Once you complete a cycle, you will move to the next cycle. You will repeat these cycles until you stop being in the study. Your total time in the study is not defined and will depend on how your cancer responds to study treatment with SPYK04.
Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.
Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT04511845
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