The aim for this study is to determine the safety and efficacy of 67Cu-SAR-BBN in participants with Gastrin Releasing Peptide Receptor (GRPR)-expressing metastatic castrate resistant prostate cancer in patients who are ineligible for therapy with 177Lu-PSMA-617.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
64Cu-SAR-BBN
67Cu-SAR-BBN
Stanford University
Stanford, California, United States
Biogenix Molecular
Miami, Florida, United States
BAMF Health, Inc
Grand Rapids, Michigan, United States
XCancer Omaha LLC
Omaha, Nebraska, United States
Duke University
Durham, North Carolina, United States
M D Anderson Cancer Centre
Houston, Texas, United States
Maximum tolerated dose (MTD) or maximum feasible dose (MFD) of a single dose of 67Cu-SAR-BBN
MTD as determined by cohort observations of dose limiting toxicities or MFD determined by the activity of the dose to be administered, when the MTD has not been reached.
Time frame: Up to 8 weeks
Recommended dose of two doses of 67Cu-SAR-BBN
Recommended dose as determined by cohort observations of dose limiting toxicities
Time frame: Up to 14 weeks
Efficacy of 67Cu-SAR-BBN in terms of Prostate Specific Antigen (PSA) response
Proportion of participants with ≥50% decline in PSA
Time frame: Up to 5 years
Efficacy of 67Cu-SAR-BBN in terms of radiographic response
Efficacy will be assessed via the overall response rate according to RECIST V1.1 for soft tissue disease and according to PCWG3 for bone lesions
Time frame: Up to 5 years
Incidence of dose limiting toxicities [Safety and tolerability] of 67Cu-SAR-BBN
Incidence of dose limiting toxicities following a single administration of 67Cu-SAR-BBN
Time frame: Up to 8 weeks
Incidence of dose limiting toxicities [Safety and tolerability] of 67Cu-SAR-BBN
Incidence of dose limiting toxicities following repeated administrations of 67Cu-SAR-BBN
Time frame: Up to 14 weeks
Incidence of 67Cu-SAR-BBN treatment-emergent adverse events [Safety and tolerability]
Adverse Events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5, following single or repeated administrations of 67Cu-SAR-BBN
Time frame: Up to 12 months
Incidence of 67Cu-SAR-BBN adverse event of special interest [Safety and tolerability]
Protocol defined adverse event of special interest following single or repeated administrations of 67Cu-SAR-BBN
Time frame: Up to 5 years
Safety and tolerability of 67Cu-SAR-BBN: Number of Participants with changes from baseline in vital signs
Change from baseline in vital signs following single or repeated administrations of 67Cu-SAR-BBN
Time frame: Up to 24 weeks
Safety and tolerability of 67Cu-SAR-BBN: Number of Participants with changes from baseline in electrocardiogram (ECG) parameters
Change from baseline in ECG parameters following single or repeated administrations 67Cu-SAR-BBN
Time frame: Up to 24 weeks
Safety and tolerability of 67Cu-SAR-BBN: Number of Participants with changes from baseline in laboratory results
Change from baseline in laboratory results following single or repeated administrations 67Cu-SAR-BBN
Time frame: Up to 52 weeks
Incidence of 64Cu-SAR-BBN treatment-emergent adverse events [Safety and tolerability]
Adverse Events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5, following single or repeated administrations of 64Cu-SAR-BBN
Time frame: Up to 12 months
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