Clinical Trials | A Phase 1, Open-Label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination in Patients with Advanced KRAS G12D Mutant Solid Tumors

The UVA Comprehensive Cancer Center seeks adults ages 18 and over with Advanced KRAS G12D Mutant Solid Tumors. The purpose of this study is to measure the safety and effectiveness of an investigational drug VS-7375 and find out what the best dose of the study drug will be. Another goal of the study is to see if the study drug will provide a treatment benefit to patients with solid tumors that have a KRAS G12D mutation, such as CRC, PDAC, or NSCLC. The study drug is considered investigational because it has not been approved for sale by the United States Food and Drug Administration (FDA). The study will also test if VS-7375 can safely be combined with other treatments that are already approved by the FDA to treat certain types of cancers. The other cancer treatments to be used in this study are: • Cetuximab • Carboplatin, Pemetrexed and Pembrolizumab • Gemcitabine with or without Nab-Paclitaxel The study will be conducted in four main parts, Part A, Part B, Part C and Part D. Which drugs you receive will depend on which part of the study you participate in. You will continue to receive the study drug(s) as long as you are getting a benefit. How long you remain on treatment depends on how well your cancer responds and how well you are able to tolerate any side effects that you may experience. The study involves receiving the investigational drugs, 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 participate the study will consist of three periods: screening, study treatment, and follow-up. The screening period is where the study team will see if you are eligible for the study. After screening, if you are deemed eligible for participation, you will enter the treatment period where you will receive the study drugs and participate in study visits. The amount of visits per treatment cycle will depend on which study drugs you will receive. Study drug treatment will be stopped by your study doctor if you have side effects that you cannot tolerate or if your cancer worsens. There will be an End of Study Treatment Visit 30 days following the decision to stop study drugs. The follow-up period will consist of being contacted by the study site staff every 3 months for up to 2 years and asked how you are doing and to see if you started any new medicine for your cancer. This can be done over the telephone. The study drugs, VS-7375 and cetuximab, the study visits, and medical and laboratory tests related to the research part of the study will be paid for by the Sponsor, through the study site. You will not need to pay for any tests or procedures that are done for the sole purpose of this study. Additional information can be found here: https://clinicaltrials.gov/study/NCT07020221 [email protected]