Safety, Tolerability, Pharmacokinetics, Radiation Dosimetry, and PET Imaging Properties of 89Zr-labeled hNd2 (NMK89) in Patients With Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT06129422
- Lead Sponsor
- Nihon Medi-Physics Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria:<br><br> 1. Willing and able to provide informed consent.<br><br> 2. Male or female = 18 years of age.<br><br> 3. Histologically confirmed diagnosis of pancreatic adenocarcinoma.<br><br> 4. Willing to provide biopsy specimens for purposes of confirmation of MUC5AC<br> expression.<br><br> 5. Confirmed MUC5AC expression at pre-screening.<br><br> 6. Measurable disease.<br><br> 7. Female patients of child-bearing potential must have a negative serum pregnancy test<br> within 30 days prior to infusion of NMK89.<br><br> 8. Willing to comply with the study protocol requirements.<br><br> 9. Willing to provide a tumor resection specimen or biopsy specimen, if the patient<br> undergoes tumor resection or biopsy between Day 16 and Day 60.<br><br>Exclusion Criteria:<br><br> 1. Known hypersensitivity to the investigational medicinal product (IMP) or any of the<br> excipients.<br><br> 2. History of another primary cancer within the 2 years prior to enrollment, except for<br> the curatively treated in situ cancers.<br><br> 3. Exposure to any investigational treatments within 30 days prior to the planned date<br> of infusion of NMK89.<br><br> 4. Ongoing toxicity = Grade 2.<br><br> 5. Pleural effusion or peritoneal fluid = Grade 3.<br><br> 6. Active hepatitis B, hepatitis C, HIV, or other progressing infectious disease.<br><br> 7. Uncontrolled diabetes.<br><br> 8. Autoimmune disease or idiopathic thrombocytopenic purpura.<br><br> 9. Exposure to any radiopharmaceuticals.<br><br> 10. Planned antineoplastic therapies on the planned date of NMK89 infusion.<br><br> 11. Use of bevacizumab or any other anti-angiogenic agent.<br><br> 12. Uncontrolled intercurrent illness.<br><br> 13. ECOG PS: = 2.<br><br> 14. Participants do not have adequate organ and marrow function.<br><br> 15. Female patients that are pregnant or breast-feeding.<br><br> 16. Positive urine screen for illegal drugs, or abuse of prescribed drugs at Screening.<br><br> 17. Participants with contraindications to contrast agent injection used for diagnostic<br> CT.<br><br> 18. Deemed inappropriate to participate by the investigator.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method