Clinical Trials | A Phase 1 First in Human Study of ARV-393 in Adult Participants with Advanced Non-Hodgkin’s Lymphoma

The University of Virginia is conducting a clinical research study for adults ages 18 years and over with Advanced Non-Hodgkin Lymphoma. The purpose of this research study is to find out whether or not the study drug, ARV-393, may be used in the future as a possible treatment for Advanced Non-Hodgkin Lymphoma. This study has 2 Parts and approximately 152 adults will participate across all parts. You are being asked to participate in Part A or Part B. The main purpose of Part A is to learn how safe and tolerable ARV-393 is. The main purpose of Part B is to determine the best doses of ARV-393. • Participants enrolled in Part A will be split into cohorts (or groups). Each cohort, or group, will receive a different, and potentially, higher dose than the last cohort. Depending on your cohort, you will receive anywhere from 5 mg to 80 mg daily of ARV-393. Your individual dose may also be increased if you are tolerating ARV- 393 well and the higher dose is deemed to be safe. This process will help the study doctor determine the safest and most tolerable dose of ARV-393. • Participants enrolled in Part B will receive 1 of 2 doses: the dose determined to be the highest dose that is safe and tolerable in Part A, or a lower dose. You will have an equal chance of receiving either dose. You may be in this study for up to 2 years after your last dose of ARV-393. You will receive ARV-393 for as long as it is helping you. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. Additional information can be found here: https://clinicaltrials.gov/study/NCT06393738 [email protected]