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

Phase 1

Conditions: Metastatic Bladder Cancer
Cancer - Bladder

Registration Number: ACTRN12624000824561

Lead Sponsor: niversity of Queensland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 20

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 ALTless than or equal to 2.5 x ULN
Serum bilirubinless than or equal to 1.5 x ULN
eGFRGFR 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