- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2023-10-31
2025-11-30
2025-11-30
10
NCT06129422
Nihon Medi-Physics Co., Ltd.
Nihon Medi-Physics Co., Ltd.
INTERVENTIONAL
Safety, Tolerability, Pharmacokinetics, Radiation Dosimetry, and PET Imaging Properties of 89Zr-labeled hNd2 (NMK89) in Patients With Pancreatic Cancer
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)
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-10-27 | N/A | 2025-06-10 |
2023-11-08 | N/A | 2025-06-11 |
2023-11-13 | N/A | 2025-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: NMK89 Patients will receive a single infusion of NMK89 | DRUG: NMK89
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Safety and tolerability of a single infusion of NMK89: physical examination 1 | Body weight | Screening to Day 8 |
| Safety and tolerability of a single infusion of NMK89: physical examination 2 | Height | Screening |
| Safety and tolerability of a single infusion of NMK89: vital sign 1 | Body temperature | Screening to Day 8 |
| Safety and tolerability of a single infusion of NMK89: vital sign 2 | Heart rate | Screening to Day 8 |
| Safety and tolerability of a single infusion of NMK89: vital sign 3 | Systolic blood pressure (SBP) | Screening to Day 8 |
| Safety and tolerability of a single infusion of NMK89: vital sign 4 | Diastolic blood pressure (DBP) | Screening to Day 8 |
| Safety and tolerability of a single infusion of NMK89: 12-lead ECG (Electrocardiogram) 1 | PR interval | Screening to Day 8 |
| Safety and tolerability of a single infusion of NMK89: 12-lead ECG 2 | RR interval | Screening to Day 8 |
| Safety and tolerability of a single infusion of NMK89: 12-lead ECG 3 | QRS interval | Screening to Day 8 |
| Safety and tolerability of a single infusion of NMK89: 12-lead ECG 4 | QT | Screening to Day 8 |
| Safety and tolerability of a single infusion of NMK89: 12-lead ECG 5 | Corrected QT | Screening to Day 8 |
| 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)) | Baseline up to Day 60 | |
| 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. | Screening to Day 8 |
| 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. | Screening to Day 8 |
| 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). | Screening to Day 8 |
| 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. | Screening to Day 8 |
| Safety and tolerability of a single infusion of NMK89: Frequency and severity of abnormal ECOG PS (Eastern Cooperative Oncology Group Performance Status) | Screening to Day 8 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | Day 1 to Day 8 |
| 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. | Day 1 to Day 8 |
| Radiation Dosimetry of NMK89: Normalized radiation absorbed doses and normalized effective dose | Whole-body radiation dosimetry of NMK89 in patients will be estimated. | Day 1 to Day 8 |
| 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. | Day 1 to Day 8 |
| 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. | Day 1 to Day 8 |
| 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. | Pre-infusion (baseline) to Day 8 |
| 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. | Day 1 to Day 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 | Day 1 to Day 8 |
| 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. | Pre-infusion (baseline) to Day 8 |
| 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. | Day 1 to Day 8 |
| 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. | Day 1 to Day 8 |
| Biological half-life of the radionuclide (hr) | Biological half-life of the radionuclide (hr) will also be estimated. | Day 1 to Day 8 |
| Public Safety: Radiation measurement | Public safety will be assessed by acquiring dosimeter readings of a patient following infusion. | Day 1 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
