Pancreatic Cancer Research

Clinical trialPhase 1Completed

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

Outcome
Finished, no results posted
Phase
Phase 1
Status
Completed
Study type
Interventional
Start
31 October 2023
Expected end
7 October 2025
Enrollment
10 participants
Sites
3
Primary outcomes
Safety and tolerability of a single infusion of NMK89: physical examination 1; Safety and tolerability of a single infusion of NMK89: physical examination 2; Safety and tolerability of a single infusion of NMK89: vital sign 1; Safety and tolerability of a single infusion of NMK89: vital sign 2; Safety and tolerability of a single infusion of NMK89: vital sign 3
Sponsor
Industry
Results posted
No
Last update
26 November 2025

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Brief summary public domain (ClinicalTrials.gov)

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)