RecruitingPhase 1ACTRN12624000824561

Clearview-BC: 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 Bladder Cancer

Clearview-BC: A phase 1 PET-CT study to evaluate the safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 in patients with Bladder Cancer

Sponsor

University of Queensland

Enrollment

20 participants

Start Date

Nov 1, 2024

Study Type

Interventional

Conditions

Metastatic Bladder Cancer

Summary

This study aims to evaluate the safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 to detect known tumour deposits in patients with metastatic bladder cancer. Who is it for? You may be eligible for this study if you are an adult with recurrent, histologically proven bladder 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 bladder cancer metastases in humans and therefore prove its potential utility as a theranostic in ovarian cancer.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Bladder cancer that has spread to other parts of the body (metastatic bladder cancer) is very difficult to treat, and there is an ongoing need for better ways to detect and target tumour deposits. This Phase 1 study is testing a new imaging agent called 89Zr-hu/mo-10D7, which is designed to attach to a specific protein (CDCP1) found on bladder cancer cells and make tumours visible on a PET/CT scan. By helping doctors see exactly where cancer has spread in the body, this kind of imaging could eventually be used to guide more precise, targeted treatments. In this early-phase study, researchers are primarily checking whether the agent is safe and how it behaves in the body. You may be eligible if you are an adult with recurrent, confirmed bladder cancer that has visible metastatic deposits on standard imaging scans, and your tumour has been shown to express the CDCP1 protein. You must have reasonable organ function and not be pregnant or breastfeeding.

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)

Mater Hospital Brisbane - South Brisbane

QLD, Australia

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

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