Clinical Trials | A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of NDI-219216 as a Single Agent in Patients with Advanced Solid Tumors with and without Microsatellite Instability and/or Deficient Mismatch Repair

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Advanced Solid Tumors with and without Microsatellite Instability and/or Deficient Mismatch Repair. The purpose of this study is to explore whether or not an experimental investigational new drug, NDI-219216, is safe for participants, and also if it might be a possible treatment for advanced solid tumors in the later phases of the study. “Investigational new drug” means a drug that has not been approved as a marketed product (i.e., available to be prescribed or sold) by the United States (US) Food and Drug Administration (FDA; or any comparable regulatory agency anywhere else in the world). This study is being done in two phases, with three “parts” to the study. Phase 1 of this study is the “dose escalation phase” and will be done in two Parts, A and B. Phase 2 of this study is the “expansion phase” and is also called Part C. The study involves receiving the investigational drug, as well as coming in for study visits, which include exams, laboratory tests, imaging scans, procedures such as having your blood drawn, and talking to the study doctor. If you decide to take part in this research study, you will need to visit the study site for screening to see if you qualify for this study. Once you begin taking the study drug, the study will be divided into treatment “cycles” of 28 days each and you will visit the study site 6 times during the first cycle. During the second cycle, you will attend 2 visits at the study site. You will then visit the study site monthly (once per cycle) until you discontinue (this does not include any unscheduled visits that may be needed). Not everyone will stay in the study for the same amount of time. The number of cycles you receive will depend on how your body reacts to the study drug, as well as your overall health and the stability of your cancer. Following your last dose of study drug, you will return to the clinic for the End of Study Treatment visit. The study drugs, NDI-219216,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, and visits to the study center, are provided to you at no charge. Additional information can be found here: https://clinicaltrials.gov/ [email protected]