This is a study of ATG-031 in people with advanced solid tumors or B-cell Non-Hodgkin Lymphomas. The study has two parts. A Dose Escalation Phase and a Dose Expansion Phase. During the Dose Escalation Phase, you will be placed in small groups called cohorts. Each cohort will receive a different dose of ATG-031. The first group will start at the lowest dose, and if that dose is safe, the next group will receive a higher dose. This will continue until the highest dose that people safely tolerate is found. In the later Dose Expansion Phase, more people who join will receive the drug at the safe dose to further test how well it works and how safe it is. This part is not included in your consent right now. If you join the study, you will first have a screening period of up to 28 days to see if you are eligible. During these visits, you will have blood draws, heart tests, scans, and a physical exam. If you qualify, you will move into the Treatment Period. In this period, you will be given study drug through an IV infusion, which can take several hours, in repeating cycles. Each cycle will last either 21 or 28 days, depending on which group you are assigned to. Some groups will have a smaller dose before moving to the full dose. During each cycle, you will also have exams, blood draws, and scans to check your health and how the cancer is responding. You may continue treatment as long as it is helping you, and the side effects are not severe. After treatment ends, you will have an End of Treatment visit within 14 days. You will be followed by the study team for 90 days after the study ends and contacted every 3 months after that to check on your health.

Who can Participate

You may be eligible to join the study if you are 18 years old or older, have B-cell non-Hodgkin lymphomas or advanced solid tumors, and cancer that has come back or has not responded to standard treatments. You must be in good overall health to undergo study procedures. You must be able to come in person for study visits and exams. Women who can become pregnant must have a negative pregnancy test before starting. Both men and women must use reliable birth control during the study and for 6 months afterwards. You cannot join if you are pregnant, breastfeeding, or planning to become pregnant during the study. You cannot join the study if you have other health conditions, serious heart problems, or active infections. Your doctor and study team will review your health before any treatments to make sure it is safe to participate. You can visit ClinicalTrials.gov to learn more about this study.

Study ID

More information available at ClinicalTrials.gov: NCT06028373