Clinical Trials | A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants With Gastrointestinal Cancers

The University of Virginia Comprehensive Cancer Center is enrolling adults ages 18 and over with Gastrointestinal Cancers for a clinical trial. In this trial, researchers are trying to find out if an investigational trial drug called raludotatug deruxtecan (R-DXd, MK-5909 or DS-6000a) is safe and if it may help stop the growth of these cancers. Raludotatug deruxtecan is investigational, meaning it has not been approved for the treatment of canceru. Everyone in this trial will receive the investigational trial drug and visit the trial site on a regular schedule. These trial visits will , include exams, laboratory tests, and procedures such as having your blood drawn, and talking to the trial doctor. The trial includes 3 phases: Screening, Treatment, and Follow-Up. The screening period will last about a month, with at least 1 visit to the trial site. During the Treatment Phase, you will visit the trial site about 5 times during the first 3 weeks and then 1 time every 3 weeks. How long you will be in the trial depends on your health and how well you tolerate the investigational trial drug. After you stop getting the investigational trial drug, you will enter the follow-up phase. You will have a follow-up visit about 40 days after your last treatment. You will then have follow-up visits about every 6 weeks as long as your cancer does not get worse and you do not start a new cancer treatment. After you stop having follow-up visits, the trial doctor or staff will contact you about every 12 weeks to check on your health. The investigational study drug, will be provided by the sponsor at no cost to you. All additional study procedures that are beyond your standard medical care, including laboratory tests, physical examinations, imaging, and visits to the study center, are provided to you at no cost. You may also be reimbursed for study related travel expenses. Additional information can be found here: https://clinicaltrials.gov/study/NCT06864169 [email protected]