Clinical Trials | Testing the effectiveness of the anti-cancer drug pidnarulex (CX-5461) in combination with another anti-cancer drug cemiplimab (REGN2810), in treating refractory microsatellite stable colorectal cancer

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Refractory Microsatellite Stable Colorectal Cancer. The purpose of this study is to find out whether pidnarulex (CX-5461) plus cemiplimab (REGN2810) is better than pidnarulex (CX-5461) alone at shrinking colorectal cancer which has spread to your liver. This study will also answer the question of what is the highest dose of pidnarulex (CX-5461) and cemiplimab (REGN2810) in combination that can be safely and tolerably taken in colorectal cancer that has spread? Cemiplimab (REGN2810) has been approved by the FDA to treat other cancers, but cemiplimab (REGN2810) and pidnarulex (CX-5461) have not been approved by the FDA for treatment of your disease. If you participate in the phase 1 portion of the study, you will get pidnarulex (CX-5461) through a vein in your arm on the first and eighth day of each cycle. This will take approximately 60 minutes. You will get cemiplimab (REGN2810) through a vein in your arm on the first and fifteenth (15) day of each cycle. The Phase 2 portion of the study has two treatment groups: • Group 1: If you are in this group, you will get pidnarulex (CX-5461) through a vein in the arm and on the first and eighth day of each cycle. This will take approximately 60 minutes. Each cycle lasts 28 days. • Group 2: If you are in this group, you will get pidnarulex (CX-5461) and cemiplimab (REGN2810), through a vein in the arm. You will get pidnarulex (CX-5461) on the first and eighth day of each cycle. This will take approximately 60 minutes. You will also get cemiplimab (REGN2810), through a vein in your arm on the first and fifteenth (15) day of each cycle. This will take approximately 30 minutes. Each cycle lasts 28 days. We will use a computer to assign you to one of the study groups. This process is called “randomization.” It means that your doctor will not choose, and you cannot choose which study group you are in. The study involves receiving the investigational drug, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, imaging, and talking to the study doctor. If you choose to take part and are deemed eligible for participation, you will receive the investigational drugs according to the group you have been assigned. You will continue treatment unless your disease gets worse, or the side effects become too severe, for up to 26 cycles (about 2 years). After you finish your study treatment, your doctor and study team will watch you for side effects. They will check on you every 3 months for 2 years after treatment. This may be done via telephone calls, in-person clinic visits, or a combination of the two. You and/or your insurance plan will need to pay for the costs of medical care you get as part of the study, just as you would if you were getting the usual care for your cancer. You or your insurance provider will not have to pay for the pidnarulex (CX-5461) and cemiplimab (REGN2810) while you take part in this study. Additional information can be found here: https://clinicaltrials.gov/study/NCT07147231 [email protected]