Evaluating a new imaging agent for pancreatic cancer

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 study is testing a new imaging agent to see if it can help doctors better visualize pancreatic tumors in patients who have a specific marker called MUC5AC.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nihon Medi-Physics Co., Ltd. (Industry-sponsored)
• Drugs / interventions: bevacizumab, radiation
• Locations: 3 sites (Tampa, Florida and 2 other locations)
• Trial ID: NCT06129422 on ClinicalTrials.gov

What this trial studies

This Phase I trial aims to assess the safety, tolerability, and pharmacokinetics of 89Zr-labeled hNd2 (NMK89) in patients with pancreatic cancer who express MUC5AC. Participants will receive an infusion of the investigational agent, followed by PET imaging to evaluate biodistribution and radiation dosimetry. The study is non-randomized and focuses on collecting data to understand how the agent behaves in the body and its potential for imaging pancreatic tumors. The trial will also require biopsy specimens to confirm MUC5AC expression.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed pancreatic adenocarcinoma who express MUC5AC.

Not a fit: Patients with known hypersensitivity to the investigational product or those with other primary cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance imaging techniques for better diagnosis and treatment planning in pancreatic cancer patients.

How similar studies have performed: While similar imaging approaches have been explored, this specific use of 89Zr-labeled hNd2 in pancreatic cancer is novel.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

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.

Where this trial is running

Tampa, Florida and 2 other locations

• Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
• BAMF Health — Grand Rapids, Michigan, United States (Recruiting)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)

Conditions Pancreatic Cancer; pancreatic cancer; MUC5AC