A Phase I Trial to Assess Safety, Tolerability, Pharmacokinetics, Radiation Dosimetry, and Positron Emission Tomography (PET) Imaging Properties of 89Zr-labeled hNd2 (NMK89) in Patients With Pancreatic Cancer Histologically Positive for MUC5AC

Trial ID: NCT06129422

Interventional - Phase 1 - Completed

This trial will be a non-randomized, Phase I trial to evaluate safety, tolerability, biodistribution, radiation dosimetry, pharmacokinetics and PET imaging properties following an infusion of 37 MBq (1 mCi) of 89Zr-labeled hNd2\* (NMK89) in patients with pancreatic cancer that are positive for MUC5AC. Image acquisition is conducted using a PET/CT machine. \* hNd2: Recombinant humanized Nd2 (anti-human MUC5AC monoclonal antibody)

Conditions

• Pancreatic Cancer

Interventions

• NMK89

Eligibility

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.

Sponsor

Nihon Medi-Physics Co., Ltd.

Source: ClinicalTrials.gov

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