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

Completed · Phase 1

Conditions studied: Pancreatic Cancer

In brief

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)

Key facts

Study ID

NCT06129422

Run by

Nihon Medi-Physics Co., Ltd.

People needed

10

Starts

2023-10-31

Expected to finish

2025-10-07

Last updated by the study team

2025-11-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Known hypersensitivity to the investigational medicinal product (IMP) or any of the excipients.
• 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.
• Ongoing toxicity ≥ Grade 2.
• Pleural effusion or peritoneal fluid ≥ Grade 3.
• Active hepatitis B, hepatitis C, HIV, or other progressing infectious disease.
• Uncontrolled diabetes.
• Autoimmune disease or idiopathic thrombocytopenic purpura.
• Exposure to any radiopharmaceuticals.
• Planned antineoplastic therapies on the planned date of NMK89 infusion.
• Use of bevacizumab or any other anti-angiogenic agent.
• Uncontrolled intercurrent illness.
• ECOG PS: ≥ 2.
• Participants do not have adequate organ and marrow function.
• Female patients that are pregnant or breast-feeding.
• Positive urine screen for illegal drugs, or abuse of prescribed drugs at Screening.
• Participants with contraindications to contrast agent injection used for diagnostic CT.
• Deemed inappropriate to participate by the investigator.

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States
• BAMF Health — Grand Rapids, Michigan, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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