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

Launched by NIHON MEDI-PHYSICS CO., LTD. · Nov 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging agent called NMK89, which is designed to help doctors better visualize pancreatic cancer in patients. Specifically, the trial is focused on patients whose cancer cells show a particular marker known as MUC5AC. By injecting a small dose of NMK89 and using a special imaging machine called PET/CT, researchers want to learn about the safety of this agent, how it spreads in the body, and how well it works in spotting cancer.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with pancreatic cancer. They also need to agree to provide some tissue samples to confirm their cancer has the MUC5AC marker. Women who could become pregnant will need to take a pregnancy test before joining. Throughout the trial, participants can expect to receive the NMK89 injection and undergo imaging tests, while closely monitoring their health and any side effects. It's important to note that certain health conditions or recent treatments may prevent someone from participating, so discussing individual circumstances with a healthcare provider is essential.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• 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.