RecruitingEarly Phase 1ACTRN12624000469516

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


Sponsor

Mater Misericordiae Ltd

Enrollment

30 participants

Start Date

Feb 28, 2025

Study Type

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

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Ovarian cancer is one of the most difficult cancers to treat, partly because it is often not caught until it has spread. This early-phase study is testing a new imaging agent called 89Zr-hu/mo-10D7, which is designed to "light up" ovarian cancer tumours on a PET-CT scan by targeting a protein called CDCP1 that is found on ovarian cancer cells. The goal is to see whether this agent can accurately find cancer deposits in the body and to understand how it behaves once administered. All participants will receive a single intravenous infusion of the imaging agent and then be monitored with blood tests, vital signs checks, ECGs, urine tests, and PET-CT scans over the following days. No cancer treatment is being tested in this study — it is purely an imaging investigation. You may be eligible if you are a woman aged 18 or older with recurrent, histologically confirmed advanced ovarian cancer, with visible tumour on diagnostic imaging, a CDCP1-positive tumour sample, good general health (ECOG 0 to 1), and a life expectancy of more than 3 months. Any cancer treatment received in the last 28 days would make you ineligible.

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. Admi

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)

Mater Hospital Brisbane - South Brisbane

QLD, Australia

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

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ACTRN12624000469516