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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
Route of administration: intravenous infusion
Moffitt Cancer Center
Tampa, Florida, United States
BAMF Health
Grand Rapids, Michigan, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Safety and tolerability of a single infusion of NMK89: physical examination 1
Body weight
Time frame: Screening to Day 8
Safety and tolerability of a single infusion of NMK89: physical examination 2
Height
Time frame: Screening
Safety and tolerability of a single infusion of NMK89: vital sign 1
Body temperature
Time frame: Screening to Day 8
Safety and tolerability of a single infusion of NMK89: vital sign 2
Heart rate
Time frame: Screening to Day 8
Safety and tolerability of a single infusion of NMK89: vital sign 3
Systolic blood pressure (SBP)
Time frame: Screening to Day 8
Safety and tolerability of a single infusion of NMK89: vital sign 4
Diastolic blood pressure (DBP)
Time frame: Screening to Day 8
Safety and tolerability of a single infusion of NMK89: 12-lead ECG (Electrocardiogram) 1
PR interval
Time frame: Screening to Day 8
Safety and tolerability of a single infusion of NMK89: 12-lead ECG 2
RR interval
Time frame: Screening to Day 8
Safety and tolerability of a single infusion of NMK89: 12-lead ECG 3
QRS interval
Time frame: Screening to Day 8
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Safety and tolerability of a single infusion of NMK89: 12-lead ECG 4
QT
Time frame: Screening to Day 8
Safety and tolerability of a single infusion of NMK89: 12-lead ECG 5
Corrected QT
Time frame: 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))
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: Screening to Day 8
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 to Day 8
Biological half-life of the radionuclide (hr)
Biological half-life of the radionuclide (hr) will also be estimated.
Time frame: Day 1 to Day 8
Public Safety: Radiation measurement
Public safety will be assessed by acquiring dosimeter readings of a patient following infusion.
Time frame: Day 1