ZOvCa: A phase 1 Positron Emission Tomography (PET) - Computed Tomography (CT) study to evaluate the safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 in patients with advanced epithelial Ovarian Cancer
ZOvCa: A phase 1 PET-CT study to evaluate the safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 in patients with advanced epithelial Ovarian Cancer
Mater Misericordiae Ltd
30 participants
Feb 28, 2025
Interventional
Conditions
Summary
This study aims to evaluate the safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 to detect known tumour deposits in patients with advanced epithelial Ovarian Cancer. Who is it for? You may be eligible for this study if you are an adult with recurrent, histologically proven advanced ovarian cancer with a macroscopically visible tumour on diagnostic imaging. Study Details All participants who meet the eligibility criteria in this study will receive a single dose of 89Zr-hu/mo-10D7 as an intravenous infusion over 30 minutes to delivery maximum dose of 4.5 mg protein and 37 MBq radiation. During and after completion of the treatment participants will be assessed for safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 via vital signs, blood tests, ECG, urinalysis and PET/CT scan. It is hoped that this research project will demonstrate hu/mo-10D7 targets advanced ovarian cancer metastases in humans and therefore prove its potential utility as a theranostic in ovarian cancer.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Participants will receive a single intravenous dose of 89Zr-hu/mo-10D7 (up to 4.5 mg protein; 37 MBq radiation) as an intravenous infusion over 30 minutes under a low-risk, micro-dosing regimen. Administration of 89Zr-hu/mo-10D7 will be undertaken by Registered Nurses within the Dept of Nuclear Medicine, RBWH. Imaging PET-CT scans will be undertaken by a Nuclear Medicine Technologist at the Herston Imaging Research Facility (HIRF) at the following timepoints: Day 0 - 4 hours post infusion Day 1 - approx 24 hours post infusion Day 3* - 3 days post infusion (+/- 1 day) Day 7 - 7 days post infusion (+/- 1 day) Duration of the imaging is approximately 15-30mins. No further injections will occur post administration of the investigative agent.
Locations(2)
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ACTRN12624000469516