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

Prior treatment

• History of another primary cancer within the 2 years prior to enrollment, except for the curatively treated in situ cancers.
• Exposure to any investigational treatments within 30 days prior to the planned date of infusion of NMK89.
• Planned antineoplastic therapies on the planned date of NMK89 infusion.
• Use of bevacizumab or any other anti-angiogenic agent.
• Positive urine screen for illegal drugs, or abuse of prescribed drugs at Screening.

Other illness

• Known hypersensitivity to the investigational medicinal product (IMP) or any of the excipients.
• Active hepatitis B, hepatitis C, HIV, or other progressing infectious disease.
• Uncontrolled diabetes.
• Autoimmune disease or idiopathic thrombocytopenic purpura.
• Uncontrolled intercurrent illness.

Other

• Ongoing toxicity ≥ Grade 2.
• Pleural effusion or peritoneal fluid ≥ Grade 3.
• Exposure to any radiopharmaceuticals.
• ECOG PS: ≥ 2.
• Participants do not have adequate organ and marrow function.
• Female patients that are pregnant or breast-feeding.
• Participants with contraindications to contrast agent injection used for diagnostic CT.
• Deemed inappropriate to participate by the investigator.

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