Clinical Trials | A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 in Combination With other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous MTAP-deletion

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) with Homozygous MTAP-deletion. The purpose of this study is to learn more about an investigational drug called AMG 193 for treatment of people with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) (a type of cancer that has spread to the pancreas) with homozygous methylthioadenosine phosphorylase (MTAP) deletion. Investigational means that the drug has not been approved by the U. S. Food and Drug Administration (FDA) and is considered experimental. 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 are fit to join and take part in it, you may be in this study for up to 5 years including a screening period lasting up to 28 days, a treatment period of about 3 year until your disease progresses, a safety follow-up visit of about 30 days after the last dose of study drug then a long-term follow-up that will be conducted every 12 weeks via telephone or in clinic for up to 2 years after last dose of study drug or until withdrawal of consent or participants death, whichever occurs first. 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/NCT06360354 [email protected]