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

Eligibility Criteria

• 1. Willing and able to provide informed consent.
• 2. Male or female ≥ 18 years of age.
• 3. Histologically confirmed diagnosis of pancreatic adenocarcinoma.
• 4. Willing to provide biopsy specimens for purposes of confirmation of MUC5AC expression.
• 5. Confirmed MUC5AC expression at pre-screening.
• 6. Measurable disease.
• 7. Female patients of child-bearing potential must have a negative serum pregnancy test within 30 days prior to infusion of NMK89.
• 8. Willing to comply with the study protocol requirements.
• 9. Willing to provide a tumor resection specimen or biopsy specimen, if the patient undergoes tumor resection or biopsy between Day 16 and Day 60.
• 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.