Clinical Trials | A Phase 1/1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Advanced MTAP-null Solid Tumors. The purpose of this study is to assess whether the investigational drug AMG 193 alone and in combination with docetaxel is safe and is an effective treatment option for advanced solid tumors with MTAP loss. AMG 193 is investigational because it has not been approved by the United States Food and Drug Administration (FDA). The study drug, AMG 193, will be given as a single drug in Part 1 and AMG 193 will be given in combination with docetaxel in Part 2 of the study. 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, and talking to the study doctor. If you meet the study requirements and are enrolled you may be in this study for approximately 2 years. This includes a screening period lasting up to 28 days, a treatment period lasting until your disease progresses, you can withdraw your consent to take part, or may have to stop due to other reasons. Treatment cycles last 28 days and AMG 193 will be taken once or twice daily, and you will come in for study visits more than once per cycle for tests or procedures as well as receiving docetaxel if in Part 2 of the study. After your last dose of study treatment you will have an End of Treatment visit, a Safety Follow-up visit, and a Long-term Follow-up period to see how you are doing. The study drugs, AMG 193, 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. Patients may also be reimbursed for study-required travel or expenses. Additional information can be found here: https://clinicaltrials.gov/study/NCT05094336 [email protected]