A Phase 1 Study of RGX-104 a Small Molecule LXR Agonist as a Single Agent and as Combination Therapy in Patients with Advanced Solid Malignancies and Lymphoma with an Expansion in Select Malignancies

Brief description of study

The purpose of the study is to look at RGX-104 as a single agent, and separately, in combination with nivolumab, ipilimumab, docetaxel, or pembrolizumab plus carboplatin/pemetrexed. The first part of the study is to determine the highest tolerable dose of RGX-104 in combination with nivolumab, ipilimumab, docetaxel or pembrolizumab plus carboplatin and pemetrexed. The second part of the study is to determine if RGX-104 combined with docetaxel or pembrolizumab plus carboplatin and pemetrexed might be an effective treatment option for people with advanced cancers. Both parts of the study will try to understand the safety and side effects of RGX-104 when given as a combination therapy, as well as how the drug moves through the body and how it affects various types of cells in your blood and cancer. RGX-104 is a drug that binds to proteins, called Liver X receptors (LXRs) that are in the cells of our body. The study drug RGX-104 is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.




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