Trials / Completed
CompletedNCT06129422
Safety, Tolerability, Pharmacokinetics, Radiation Dosimetry, and PET Imaging Properties of 89Zr-labeled hNd2 (NMK89) in Patients With 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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Nihon Medi-Physics Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NMK89 | Route of administration: intravenous infusion |
Timeline
- Start date
- 2023-10-31
- Primary completion
- 2025-10-07
- Completion
- 2025-10-07
- First posted
- 2023-11-13
- Last updated
- 2025-11-26
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06129422. Inclusion in this directory is not an endorsement.