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 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.
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
Mater Misericordiae Ltd
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
• Adults (equal or greater than 18 years) with recurrent, histologically proven advanced ovarian cancer. • Macroscopically visible tumour on diagnostic CT with contrast and FDG-PET/CT imaging. • CDCP1 expression proven on tumour sample. • ECOG 0-1 • Expected survival more than 3 months • 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 (acceptable range less than or equal to 2.5 x ULN) and Serum bilirubin (acceptable range less than or equal to 1.5 x ULN)
Exclusion criteria
• Use of anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, or any investigational therapy within 28 days prior to administration of 89Zr-hu/mo-10D7. • History of major immunologic reaction to any IgG containing agent. • Medical condition(s) which places the subject at an unacceptably high risk. • Subject is pregnant, lactating, or unwilling/unable to use adequate contraception.
Outcome results
None listed