Clinical Trials | A Phase 1 Study of IM-1021 in Participants with Advance Malignancies

The University of Virginia is conducting a clinical research study for adults ages 18 and over with advanced B-cell lymphomas. The purpose of this study is to test different doses of IM-1021 to see which dose or doses are safe in people. IM-1021 is a type of drug called an antibody drug conjugate, or “ADC”. IM-1021 is designed to stick to a protein called ROR1 on certain cells in the body including cancer cells. When stuck to ROR1 on a cancer cell, IM-1021 is designed to deliver a drug to the cell that will kill it. This study may also test the safety of IM-1021 given on a different schedule (or frequency) of dosing and to find out what its side effects are and if it works against your cancer. This study has 2 groups: Part A (Dose-Escalation) and Part B (Dose-Expansion). Which group you will be in depends on what type of cancer you have and what part of the study is enrolling participants when you enroll. Your study doctor will let you know which part of the study you will be in. You will receive IM-1021 as an intravenous (IV) into one of your veins. This will be given either: • Once every 3 weeks (a 3-week “cycle”), • Once weekly in 3-week cycles, or • Once weekly for 2 weeks followed by 1 week off in 3-week cycles. The infusion may take 30 minutes, or may take longer, depending on how you feel while being given IM-1021. You will receive the study drug as long as you are doing well and your cancer is not getting worse. 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/NCT06823167 [email protected]