COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

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

Quick Facts

Study Start:2023-10-31

Study Completion:2025-10-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06129422

Participation Criteria

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Willing and able to provide informed consent. 2. Male or female ≥ 18 years of age. 3. Histologically confirmed diagnosis of pancreatic adenocarcinoma. 4. Willing to provide biopsy specimens for purposes of confirmation of MUC5AC expression. 5. Confirmed MUC5AC expression at pre-screening. 6. Measurable disease. 7. Female patients of child-bearing potential must have a negative serum pregnancy test within 30 days prior to infusion of NMK89. 8. Willing to comply with the study protocol requirements. 9. Willing to provide a tumor resection specimen or biopsy specimen, if the patient undergoes tumor resection or biopsy between Day 16 and Day 60.	1. Known hypersensitivity to the investigational medicinal product (IMP) or any of the excipients. 2. History of another primary cancer within the 2 years prior to enrollment, except for the curatively treated in situ cancers. 3. Exposure to any investigational treatments within 30 days prior to the planned date of infusion of NMK89. 4. Ongoing toxicity ≥ Grade 2. 5. Pleural effusion or peritoneal fluid ≥ Grade 3. 6. Active hepatitis B, hepatitis C, HIV, or other progressing infectious disease. 7. Uncontrolled diabetes. 8. Autoimmune disease or idiopathic thrombocytopenic purpura. 9. Exposure to any radiopharmaceuticals. 10. Planned antineoplastic therapies on the planned date of NMK89 infusion. 11. Use of bevacizumab or any other anti-angiogenic agent. 12. Uncontrolled intercurrent illness. 13. ECOG PS: ≥ 2. 14. Participants do not have adequate organ and marrow function. 15. Female patients that are pregnant or breast-feeding. 16. Positive urine screen for illegal drugs, or abuse of prescribed drugs at Screening. 17. Participants with contraindications to contrast agent injection used for diagnostic CT. 18. Deemed inappropriate to participate by the investigator.

Inclusion Criteria

Exclusion Criteria

1. Willing and able to provide informed consent.
2. Male or female ≥ 18 years of age.
3. Histologically confirmed diagnosis of pancreatic adenocarcinoma.
4. Willing to provide biopsy specimens for purposes of confirmation of MUC5AC expression.
5. Confirmed MUC5AC expression at pre-screening.
6. Measurable disease.
7. Female patients of child-bearing potential must have a negative serum pregnancy test within 30 days prior to infusion of NMK89.
8. Willing to comply with the study protocol requirements.
9. Willing to provide a tumor resection specimen or biopsy specimen, if the patient undergoes tumor resection or biopsy between Day 16 and Day 60.

1. Known hypersensitivity to the investigational medicinal product (IMP) or any of the excipients.
2. History of another primary cancer within the 2 years prior to enrollment, except for the curatively treated in situ cancers.
3. Exposure to any investigational treatments within 30 days prior to the planned date of infusion of NMK89.
4. Ongoing toxicity ≥ Grade 2.
5. Pleural effusion or peritoneal fluid ≥ Grade 3.
6. Active hepatitis B, hepatitis C, HIV, or other progressing infectious disease.
7. Uncontrolled diabetes.
8. Autoimmune disease or idiopathic thrombocytopenic purpura.
9. Exposure to any radiopharmaceuticals.
10. Planned antineoplastic therapies on the planned date of NMK89 infusion.
11. Use of bevacizumab or any other anti-angiogenic agent.
12. Uncontrolled intercurrent illness.
13. ECOG PS: ≥ 2.
14. Participants do not have adequate organ and marrow function.
15. Female patients that are pregnant or breast-feeding.
16. Positive urine screen for illegal drugs, or abuse of prescribed drugs at Screening.
17. Participants with contraindications to contrast agent injection used for diagnostic CT.
18. Deemed inappropriate to participate by the investigator.

Contacts and Locations

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33612

United States

BAMF Health

Grand Rapids, Michigan, 49503

United States

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Nihon Medi-Physics Co., Ltd.

Study Record Dates

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

Study Start Date2023-10-31

Study Completion Date2025-10-07

Study Record Updates

Study Start Date2023-10-31

Study Completion Date2025-10-07

Terms related to this study

Keywords Provided by Researchers

pancreatic cancer
MUC5AC

Additional Relevant MeSH Terms

Pancreatic Cancer