This phase I trial tests best new dose, timing and effectiveness of positron emission tomography (PET) imaging using 64Cu-sarophagine-labeled tetrazine radioligand (64Cu-Tz-SarAr) and trans-cyclooctene-modified humanized 5B1 immunoconjugate (hu5B1-TCO) in patients with pancreatic, bladder or colorectal cancer or solid tumors with elevated CA 19.9 levels that have spread to nearby tissue or lymph nodes (locally advanced) or that have spread from where it first started (primary site) to other places in the body (metastatic). A PET scan is a procedure in which a small amount of radioactive tracer is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up. Because tumor cells can often take up more tracer than normal cells, the pictures can be used to find tumor cells in the body. 64Cu-Tz-SarAr is a type of radioactive tracer that gives off a small amount of radioactivity as it travels through the body. Hu5B1-TCO, a protein made by the immune system to help fight infections and other harmful processes/cells/molecules, is an antibody that attaches to a protein on pancreatic tumor cells called CA19-9. 64CuTz-SarAr then attaches to hu5B1-TCO and gives off a small amount of radioactivity, making it easier for the PET scanner to find tumor cells that are CA19-9 positive. Using this method of imaging may provide a better way of viewing and monitoring locally advanced or metastatic pancreatic, bladder, colorectal cancer or solid tumors with elevated CA 19.9 levels.
Additional locations may be listed on ClinicalTrials.gov for NCT05737615.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To assess the pharmacokinetics and organ dosimetry of the sequential intravenous administration and imaging with hu5B1-TCO and 64Cu-Tz-SarAr.
II. To determine the optimal antibody mass of hu5B1-TCO administered intravenously along with the sequential administration with 64Cu-Tz-SarAr.
III. To determine the best interval between the sequential intravenous administration of hu5B1-TCO and 64Cu-Tz-SarAr.
SECONDARY OBJECTIVES:
I. To assess the safety of the combined infusion of hu5B1-TCO and 64Cu-Tz-SarAr.
II. To evaluate the tumor targeting and imaging characteristics of sequential administration of hu5B1-TCO and 64Cu-Tz-SarAr.
III. To determine the immunogenicity of the sequential intravenous administration and imaging with hu5B1-TCO and 64Cu-Tz-SarAr.
OUTLINE: This is a dose-escalation study, followed by a dose-expansion study.
PART A: Patients are assigned to 1 of 2 arms.
ARM I: Patients receive hu5B1-TCO intravenously (IV) over 30 to 60 minutes. Patients then receive 64Cu-Tz-SarAr IV over 5-10 minutes 3 days later followed by PET scans at 1-2 hours, 3-4 hours, 18-24 hours and optionally at 36-48 hours. Patients may undergo standard of care surgery or biopsy within 120 hours of receiving 64Cu-Tz-SarAr. Patients also undergo blood sample collection throughout the study.
ARM II: Patients receive hu5B1-TCO IV over 30 to 60 minutes. Patients then receive 64Cu-Tz-SarAr IV over 5-10 minutes 5 days later followed by PET scans at 1-2 hours, 3-4 hours, 18-24 hours and optionally at 36-48 hours. Patients may undergo standard of care surgery or biopsy within 120 hours of receiving 64Cu-Tz-SarAr. Patients also undergo blood sample collection throughout the study.
PART B: Patients receive hu5B1-TCO IV over 30 to 60 minutes. Depending upon results of arm I and II, patients receive 64Cu-Tz-SarAr IV over 5-10 minutes 3 or 5 days followed by a PET scan. Patients may undergo standard of care surgery or biopsy within 120 hours of receiving 64Cu-Tz-SarAr. Patients also undergo blood sample collection throughout the study.
After completion of study interventions, patients are followed up at 5-6 weeks.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorSomali Gavane
