None listed
Conditions
Brief 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.
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
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.
Sponsors
University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Provide a signed and dated informed consent form • Be willing to comply with all study procedures and be available for the duration of the study • Adults greater than or equal to 18 years • Have histologically proven invasive bladder cancer • Visible metastatic disease on diagnostic CT and/or FDG-PET imaging • CDCP1 expression proven on tumour sample • ECOG 0-1 • Expected survival more than 3 months • Women of reproductive potential must use highly effective contraception and abstain from getting period during the trial period • Adequate organ function. Out of range values that are not clinically significant will be permitted, except for the following laboratory parameters, which must be within the ranges specified: Serum AST and ALT less than or equal to 2.5 x ULN Serum bilirubin less than or equal to 1.5 x ULN eGFR GFR greater than or equal to 30 mL/min/ 1.73 m²
Exclusion criteria
• History of major immunologic reaction to any IgG containing agent • Prior or ongoing clinically significant illness, medical condition(s), surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality that, in the investigator’s opinion, could places the subject at an unacceptably high risk, adversely affect the safety of the subject or impair the assessment of study results • Subject is pregnant, lactating, or and/or plans to become pregnant within the trial period • Exposure within the past 5 years to chimeric or murine antibodies • Exposure to a radiopharmaceuticals within the washout period (washout 10 half-lives of the radionuclide) • Concurrent participation in another clinical trial
Outcome results
None listed