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
Abstract
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: Pancreatic Cancer.
Primary outcome: 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; Safety and tolerability of a single infusion of NMK89: vital sign 4; Safety and tolerability of a single infusion of NMK89: 12-lead ECG (Electrocardiogram) 1; Safety and tolerability of a single infusion of NMK89: 12-lead ECG 2; Safety and tolerability of a single infusion of NMK89: 12-lead ECG 3; Safety and tolerability of a single infusion of NMK89: 12-lead ECG 4; Safety and tolerability of a single infusion of NMK89: 12-lead ECG 5; Safety and tolerability of a single infusion of NMK89: Frequency and severity of abnormal adverse events (AEs) (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v 5.0)); Safety…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 10 participants or records.
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