Safety, Tolerability, Pharmacokinetics, Radiation Dosimetry, and PET Imaging Properties of 89Zr-labeled hNd2 (NMK89) in Patients With Pancreatic Cancer

Exclusion Criteria

• •1. Known hypersensitivity to the investigational medicinal product (IMP) or any of the excipients.
• •2. History of another primary cancer within the 2 years prior to enrollment, except for the curatively treated in situ cancers.
• •3. Exposure to any investigational treatments within 30 days prior to the planned date of infusion of NMK89.
• •4. Ongoing toxicity ≥ Grade 2.
• •5. Pleural effusion or peritoneal fluid ≥ Grade 3.
• •6. Active hepatitis B, hepatitis C, HIV, or other progressing infectious disease.
• •7. Uncontrolled diabetes.
• •8. Autoimmune disease or idiopathic thrombocytopenic purpura.
• •9. Exposure to any radiopharmaceuticals.
• •10. Planned antineoplastic therapies on the planned date of NMK89 infusion.
• •11. Use of bevacizumab or any other anti-angiogenic agent.
• •12. Uncontrolled intercurrent illness.
• •13. ECOG PS: ≥ 2.
• •14. Participants do not have adequate organ and marrow function.
• •15. Female patients that are pregnant or breast-feeding.
• •16. Positive urine screen for illegal drugs, or abuse of prescribed drugs at Screening.
• •17. Participants with contraindications to contrast agent injection used for diagnostic CT.
• •18. Deemed inappropriate to participate by the investigator.