A Phase I/II Open-label Two Part Study of GSK3359609 in Combination with Tremelimumab in Participants with Selected Advanced Solid Tumors

Brief description of study

The purpose of this research study is to test the combination of two new drugs in certain cancers. Up to 114 people will be in this study. The two drugs in this study are experimental which means they have not been fully tested yet and are not yet approved to treat any disease by health authorities, such as the Food and Drug Administration (FDA). These new drugs have never been tested together in people before. We would like to answer the following questions: • Is the drug combination safe and what are the side effects? • How well does the drug combination work to treat people with different types of cancers? • How does the body break down this study drug combination? • What is the best dose of the new drugs in combination to give to people in part 2 of the study? We are asking you to take part in this research study because you have a selected advanced solid tumor. The basic mechanism of action for both drugs is to try to improve the immune system’s response to their tumor. Tremelimumab and GSK3359609 (ICOS) are antibodies that do this by affecting the activity and number of certain types of T cells (a type of immune cell).


Clinical Study Identifier: s18-01740
ClinicalTrials.gov Identifier: NCT03693612


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