Study Summary
This trial hopes to find out if a new treatment is safe and effective in treating prostate cancer that can't be treated with another method.
Eligible Conditions
- Castration-resistant Prostate Cancer
- Prostate Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1 & 2
Study Objectives
12 Primary · 0 Secondary · Reporting Duration: Up to 5 years
Up to 12 months
Incidence of 64Cu-SAR-BBN treatment-emergent adverse events [Safety and tolerability]
Incidence of 67Cu-SAR-BBN treatment-emergent adverse events [Safety and tolerability]
Up to 14 weeks
Incidence of dose limiting toxicities [Safety and tolerability] of 67Cu-SAR-BBN
Recommended dose of two doses of 67Cu-SAR-BBN
Safety and tolerability of 67Cu-SAR-BBN
Up to 24 weeks
Safety and tolerability of 67Cu-SAR-BBN: Number of Participants with changes from baseline in electrocardiogram (ECG) parameters
Safety and tolerability of 67Cu-SAR-BBN: Number of Participants with changes from baseline in vital signs
Up to 5 years
Efficacy of 67Cu-SAR-BBN in terms of Prostate Specific Antigen (PSA) response
Efficacy of 67Cu-SAR-BBN in terms of radiographic response
Incidence of 67Cu-SAR-BBN adverse event of special interest [Safety and tolerability]
Up to 52 weeks
Safety and tolerability of 67Cu-SAR-BBN: Number of Participants with changes from baseline in laboratory results
Up to 8 weeks
Maximum tolerated dose (MTD) or maximum feasible dose (MFD) of a single dose of 67Cu-SAR-BBN
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
67Cu-SAR-BBN
1 of 1
Experimental Treatment
38 Total Participants · 1 Treatment Group
Primary Treatment: 67Cu-SAR-BBN · No Placebo Group · Phase 1 & 2
67Cu-SAR-BBNExperimental Group · 2 Interventions: 67Cu-SAR-BBN, 64Cu-SAR-BBN · Intervention Types: Drug, Drug
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
Clarity Pharmaceuticals LtdLead Sponsor
9 Previous Clinical Trials
317 Total Patients Enrolled
1 Trials studying Prostate Cancer
30 Patients Enrolled for Prostate Cancer
Eligibility Criteria
Age 18+ · Male Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are expected to live for at least 6 more months.
Frequently Asked Questions
Are there any available vacancies for this research project?
"As of the most recent update on April 11th, 2023; this clinical trial is not presently accepting any patients. Despite that, there are 1249 other trials actively recruiting across a variety of conditions and treatments." - Anonymous Online Contributor
Unverified Answer