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

NCT06129422 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: NMK89P101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief 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. Image acquisition is conducted using a PET/CT machine. \* hNd2: Recombinant humanized Nd2 (anti-human MUC5AC monoclonal antibody)

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; MUC5AC

Outcome Measures

Primary Outcomes (17)

• 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 Outcomes (13)

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

  Day 1 to Day 8

• Biodistribution: Time-integrated activity coefficients (TIACs) (hr)

  Day 1 to Day 8

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

  Day 1 to Day 8

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

  Day 1 to Day 8

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

  Day 1 to Day 8

Study Arms (1)

NMK89

EXPERIMENTAL

Patients will receive a single infusion of NMK89

Drug: NMK89

Interventions

NMK89 DRUG

Route of administration: intravenous infusion

NMK89

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Nihon Medi-Physics Co., Ltd.: lead

Study Sites (3)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

BAMF Health

Grand Rapids, Michigan, 49503, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Related Publications (2)

• 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.

  PMID: 35276446 BACKGROUND

• 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.

  PMID: 39237345 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 13, 2023
• Study Start: October 31, 2023
• Primary Completion: October 7, 2025
• Study Completion: October 7, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)