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Trial Title:
Safety, Tolerability, Pharmacokinetics, Radiation Dosimetry, and PET Imaging Properties of 89Zr-labeled hNd2 (NMK89) in Patients With Pancreatic Cancer
NCT ID:
NCT06129422
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
pancreatic cancer
MUC5AC
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
NMK89
Description:
Route of administration: intravenous infusion
Arm group label:
NMK89
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)
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christine Darbouze
Phone:
813-745-7253
Email:
christine.darbouze@moffitt.org
Investigator:
Last name:
Kenneth Gage, MD
Email:
Principal Investigator
Facility:
Name:
BAMF Health
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clayton McNamara
Phone:
616-330-2735
Email:
Clayton.McNamara@bamfhealth.com
Investigator:
Last name:
Harshad R. Kulkarni, MD
Email:
Principal Investigator
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather White
Phone:
206-667-5534
Email:
hwhite@fredhutch.org
Investigator:
Last name:
Delphine Chen, MD
Email:
Principal Investigator
Start date:
October 31, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Nihon Medi-Physics Co., Ltd.
Agency class:
Industry
Source:
Nihon Medi-Physics Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06129422
