Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics, Radiation Dosimetry, and PET Imaging Properties of 89Zr-labeled hNd2 (NMK89) in Patients With Pancreatic Cancer
Lead Sponsor:
Nihon Medi-Physics Co., Ltd.
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 (...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Positive urine screen for illegal drugs, or abuse of prescribed drugs at Screening.
- Participants with contraindications to contrast agent injection used for diagnostic CT.
- Deemed inappropriate to participate by the investigator.
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06129422
Start Date
October 31 2023
End Date
October 7 2025
Last Update
November 26 2025
Active Locations (3)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
2
BAMF Health
Grand Rapids, Michigan, United States, 49503
3
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109