This phase I/II trial evaluates 89Zr-DFO-REGN3767 in diagnosing patients with diffuse large B cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). 89Zr-DFO-REGN3767 is an antibody agent—an antibody to which a tiny amount of radioactivity is attached. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. The antibody part of 89Zr-DFO-REGN3767 attaches to the LAG-3 protein on tumor cells. The PET scans help doctors to see where 89Zr-DFO-REGN3767 goes in the body. 89Zr-DFO-REGN3767 may help researchers find tumors that make (express) LAG-3 and identify cancer patients who will benefit from cancer-fighting drugs that target LAG-3.
Additional locations may be listed on ClinicalTrials.gov for NCT04566978.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To evaluate the pharmacokinetics (PK) and biodistribution of zirconium Zr 89-DFO-fianlimab (89Zr-DFO-REGN3767). (Part A)
II. To determine the optimal 89Zr-DFO-REGN3767 mass dose for tumor targeting.
III. To determine the optimal time for imaging and tumor uptake post 89Zr-DFO-REGN3767 administration. (Part A)
IV. To evaluate tumor lesion uptake of 89Zr-DFO-REGN3767 and correlate with LAG-3 expression by immunohistochemistry (IHC). (Part B)
SECONDARY OBJECTIVES:
I. To evaluate tumor lesion uptake of 89Zr-DFO-REGN3767 and correlate with LAG-3 expression by IHC. (Part A)
II. To evaluate tolerability of 89Zr-DFO-REGN3767. (Parts A and B)
OUTLINE: This is a phase I, dose-escalation study of 89Zr-DFO-REGN3767 followed by a phase II study. Patients are assigned to 1 of 2 parts.
PART A: Patients receive 89Zr-DFO-REGN3767 intravenously (IV) over 10-15 minutes on day 1. Patients then undergo positron emission tomography (PET) 1-4 hours after injection on day 1, between days 2-4, and between days 5-7.
PART B: Patients receive 89Zr-DFO-REGN3767 intravenously (IV) over 10-15 minutes on day 1. Patients then undergo PET on the optimal imaging day from Part A.
After completion of study, patients are followed up for 1 week after injection.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorNeeta Pandit-Taskar