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 locally advanced or metastatic epithelial cancers, including ovarian cancer, breast cancer, bladder cancer and pancreatic cancer. Who is it for? You may be eligible for this study if you are an adult with locally advanced or metastatic (cancer that has spread to other organs) ovarian, breast, bladder or pancreatic cancer with a visible tumour on diagnostic imaging. You may also be asked to provide a tumour sample for testing to ensure that you are eligible for this study as it is targeting tumours that express a specific cell surface receptor (CUB domain-containing protein 1). 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 deliver a maximum dose of 37 MBq of 89Zr-labelled antibody. 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 scans. Participants will be asked to attend a minimum of 5 study visits, with the imaging and tests described above to be completed at each visit. It is hoped that this research project will demonstrate 89Zr-hu/mo-10D7 targets locally advanced and metastatic ovarian, breast, bladder or pancreatic cancers in humans and therefore prove its potential utility as a theranostic in these cancers.
Interventions
Participants will receive a single dose of hu/mo-10D7 as an intravenous infusion over 30 minutes to deliver a maximum dose of 90 ug/Kg. Hu/mo-10D7 will be a mixture of un-labelled and labelled protein, in solution, with a total of 37 MBq of 89Zr-labelled antibody.
The principle invesitgator at nuclear medicine will administer the imaging agent.
Patients will undergo PET/CT scans at screening and full body PET scans at imaging visits
This study consists of the following hospital visits:
• Screeni
Participants will receive a single dose of hu/mo-10D7 as an intravenous infusion over 30 minutes to deliver a maximum dose of 90 ug/Kg. Hu/mo-10D7 will be a mixture of un-labelled and labelled protein, in solution, with a total of 37 MBq of 89Zr-labelled antibody. The principle invesitgator at nuclear medicine will administer the imaging agent. Patients will undergo PET/CT scans at screening and full body PET scans at imaging visits This study consists of the following hospital visits: • Screening (up to 30 days prior to injection of the imaging agent) • Day 0: Injection of the imaging agent, imaging, and assessments • Day 1: PET Imaging and assessments including vitals and bloods approx 4hrs • Day 3: Imaging and assessments including vitals and bloods approx 2hrs • Day 7: Imaging and assessments including vitals and bloods approx 2hrs
Sponsors
Mater Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
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 18 years and above Have histologically confirmed epithelial cancer Visible locally advanced or metastatic disease on conventional cross-sectional imaging (for example diagnostic contrast CT and/or FDG-PET imaging) CDCP1 expression greater than 100 proven on tumour sample by immunohistochemistry ECOG performance status of 0-1 Expected survival more than 3 months Women of reproductive potential must use highly effective contraception and abstain from getting pregnant during the trial period Adequate organ function
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 place the patient at an unacceptably high risk, adversely affect the safety of the patient or impair the assessment of study results Patient is pregnant, lactating, 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)
Outcome results
None listed