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Pancreatic CancerPhase 1NCT06129422

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

A Phase 1 study testing NMK89 in people with Pancreatic Cancer, run by Nihon Medi-Physics Co., Ltd. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
NMK89
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesUnited States
Study dates
31 Oct 2023to 7 Oct 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • BAMF Health

    Grand Rapids, Michigan, 49503

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: 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

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)
Being tested
NMK89
Keywords
pancreatic cancer, MUC5AC
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NMK89Drug

    Route of administration: intravenous infusion

Study groups in NCT06129422
Study groupRoleWhat they receive
NMK89ExperimentalPatients will receive a single infusion of NMK89
Receives: Drug: NMK89

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of a single infusion of NMK89: physical examination 1

    Body weight

    Measured: Screening to Day 8

  2. Safety and tolerability of a single infusion of NMK89: physical examination 2

    Height

    Measured: Screening

  3. Safety and tolerability of a single infusion of NMK89: vital sign 1

    Body temperature

    Measured: Screening to Day 8

  4. Safety and tolerability of a single infusion of NMK89: vital sign 2

    Heart rate

    Measured: Screening to Day 8

  5. Safety and tolerability of a single infusion of NMK89: vital sign 3

    Systolic blood pressure (SBP)

    Measured: Screening to Day 8

  6. Safety and tolerability of a single infusion of NMK89: vital sign 4

    Diastolic blood pressure (DBP)

    Measured: Screening to Day 8

  7. Safety and tolerability of a single infusion of NMK89: 12-lead ECG (Electrocardiogram) 1

    PR interval

    Measured: Screening to Day 8

  8. Safety and tolerability of a single infusion of NMK89: 12-lead ECG 2

    RR interval

    Measured: Screening to Day 8

  9. Safety and tolerability of a single infusion of NMK89: 12-lead ECG 3

    QRS interval

    Measured: Screening to Day 8

  10. Safety and tolerability of a single infusion of NMK89: 12-lead ECG 4

    QT

    Measured: Screening to Day 8

  11. Safety and tolerability of a single infusion of NMK89: 12-lead ECG 5

    Corrected QT

    Measured: Screening to Day 8

  12. Safety and tolerability of a single infusion of NMK89: Frequency and severity of abnormal adverse events (AEs) (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v 5.0))

    Measured: Baseline up to Day 60

  13. Safety and tolerability of a single infusion of NMK89: Clinical laboratory finding - hematology

    Hematology included hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), white blood cell count (total and differential: leukocytes, neutrophils, eosinophils, basophils, lymphocytes, monocytes), red blood cells, platelets.

    Measured: Screening to Day 8

  14. Safety and tolerability of a single infusion of NMK89: Clinical laboratory finding - serum chemistry

    Serum chemistry included sodium, potassium, chloride, calcium, glucose, creatinine, urea or BUN, albumin, total bilirubin, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, gamma-glutamyl transferase (GGT), lipase, amylase and total protein.

    Measured: Screening to Day 8

  15. Safety and tolerability of a single infusion of NMK89: Clinical laboratory finding - clotting factors

    Clotting factors included prothrombin time (quick), reagent-independent prothrombin ratio (international normalized ratio; INR), activated partial thromboplastin time (aPTT).

    Measured: Screening to Day 8

  16. Safety and tolerability of a single infusion of NMK89: Clinical laboratory finding - urinalysis

    Urinalysis included specific gravity, pH, protein, glucose, blood, leukocytes, ketones, nitrite, albumin, creatinine.

    Measured: Screening to Day 8

  17. Safety and tolerability of a single infusion of NMK89: Frequency and severity of abnormal ECOG PS (Eastern Cooperative Oncology Group Performance Status)

    Measured: Screening to Day 8

Secondary outcomes (13)

  1. Biodistribution: Fractional injected 89Zr radioactivity values (percentage of injected dose(%ID))

    PET/CT image acquisitions will be obtained to assess biodistribution of NMK89 in normal tissues and tumors in patients.

    Measured: Day 1 to Day 8

  2. Biodistribution: Time-integrated activity coefficients (TIACs) (hr)

    PET/CT image acquisitions will be obtained to assess biodistribution of NMK89 in normal tissues and tumors in patients.

    Measured: Day 1 to Day 8

  3. Radiation Dosimetry of NMK89: Normalized radiation absorbed doses and normalized effective dose

    Whole-body radiation dosimetry of NMK89 in patients will be estimated.

    Measured: Day 1 to Day 8

  4. Optimization of positron emission tomography (PET) Scan Protocol: Optimal time from injection to start of PET

    Optimal time from injection to start of PET acquisition will be determined.

    Measured: Day 1 to Day 8

  5. Predictive radiation dosimetry of hNd2 labeled with therapeutic radionuclide: Normalized absorbed doses and normalized effective dose

    Whole-body radiation dosimetry (if hNd2 will be labeled with a therapeutic radionuclide) will be estimated.

    Measured: Day 1 to Day 8

  6. Blood Pharmacokinetics (PK): Concentration of total antibody in blood

    PK will be evaluated based on concentration of total antibody obtained within defined volumes of blood.

    Measured: Pre-infusion (baseline) to Day 8

  7. Blood Pharmacokinetics (PK): Concentration of total radioactive counts in blood

    PK will be evaluated based on concentration of total radioactive counts obtained within defined volumes of blood.

    Measured: Day 1 to Day 8

  8. Blood Pharmacokinetics (PK): Abundance ratio of unmetabolized 89Zr-labeled hNd2(%)

    To calculate this ratio, the count of metabolites and non-metabolic components is obtained

    Measured: Day 1 to Day 8

  9. Urine Pharmacokinetics (PK): Concentration of total antibody in urine

    PK will be evaluated based on concentration of total antibody obtained within defined volumes of urine.

    Measured: Pre-infusion (baseline) to Day 8

  10. Urine Pharmacokinetics (PK): Concentration of total radioactive counts in urine

    PK will be evaluated based on concentration of total radioactive counts obtained within defined volumes of urine.

    Measured: Day 1 to Day 8

  11. Urine Pharmacokinetics (PK): Radioactivity counts of 89Zr-labeled hNd2 and metabolites components

    Radioactivity counts of 89Zr-labeled hNd2 and metabolites components are measured by magnetic separation, and the abundance ratio of unmetabolized 89Zr-labeled hNd2 (%) will be calculated.

    Measured: Day 1 to Day 8

  12. Biological half-life of the radionuclide (hr)

    Biological half-life of the radionuclide (hr) will also be estimated.

    Measured: Day 1 to Day 8

  13. Public Safety: Radiation measurement

    Public safety will be assessed by acquiring dosimeter readings of a patient following infusion.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start31 Oct 2023
  3. Primary completion7 Oct 2025
  4. Study completion7 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06129422
Sponsor's protocol ID
NMK89P101
Status last verified
Nov 2025
First submitted
27 Oct 2023
Last updated
26 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nakata N, Kobashi N, Okumura Y, Sato M, Matono M, Otsuki K, Tanaka A, Hayashi A. Radiation dosimetry and efficacy of an 89Zr/225Ac-labeled humanized anti-MUC5AC antibody. Nucl Med Biol. 2022 May-Jun;108-109:33-43. doi: 10.1016/j.nucmedbio.2022.02.003. Epub 2022 Feb 26.

    PubMed 35276446

  • Kulkarni HR, Maupin KA, Brennan T, Forsberg J, Rogers D, Olson M, Mancini BR, Chang A, Chandana SR, Kobayashi R. First-in-Human Total-Body PET/CT Imaging Using 89Zr-Labeled MUC5AC Antibody in a Patient with Pancreatic Adenocarcinoma. J Nucl Med. 2024 Nov 1;65(11):1815. doi: 10.2967/jnumed.124.268074. No abstract available.

    PubMed 39237345

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NMK89 in people with Pancreatic Cancer, run by Nihon Medi-Physics Co., Ltd. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of a single infusion of NMK89: physical examination 1 (time frame: Screening to Day 8). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06129422, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.

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