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Radiotherapeutic Agent

SAR-BBN Radiotracers for Prostate Cancer (COMBAT Trial)

Phase 1 & 2
Research Sponsored by Clarity Pharmaceuticals Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

COMBAT Trial 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.

Who is the study for?
This trial is for adults with metastatic castrate resistant prostate cancer that expresses GRPR, who can't have 177Lu-PSMA-617 therapy. They must have good kidney function, progressive bone disease visible on scans, and a positive PET/CT scan with 64Cu-SAR-BBN. Participants need to be ineligible for certain other treatments and recovered from previous therapies' side effects.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of two radioactive drugs, 64Cu-SAR-BBN and 67Cu-SAR-BBN, in targeting GRPR-expressing prostate cancer cells in patients who cannot receive another specific treatment (177Lu-PSMA-617).See study design
What are the potential side effects?
Potential side effects may include reactions related to radiation exposure such as nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. Organ-specific inflammation or damage due to targeted radioactivity could also occur.

COMBAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 64Cu-SAR-BBN treatment-emergent adverse events [Safety and tolerability]
+8 more

COMBAT Trial Design

1Treatment groups
Experimental Treatment
Group I: 67Cu-SAR-BBNExperimental Treatment2 Interventions
In the dose escalation phase: 64Cu-SAR-BBN: Patients will receive up to 2 administrations of 200MBq 67Cu-SAR-BBN: Cohorts 1 - 3: Single administration (dose will be determined based on cohort allocation). Cohort 4: 2 administrations at the recommended dose (determined by cohorts 1-3). In the cohort expansion phase: Patients will receive up to 3 administrations of 200MBq of 64Cu-SAR-BBN and 2 administrations at the recommended dose level of 67Cu-SAR-BBN, determined through the dose escalation. Additional administrations: (up to a maximum total of 4) may be offered to those participants, in either the dose escalation or cohort expansion, with radiological non-progression.

Find a Location

Who is running the clinical trial?

Clarity Pharmaceuticals LtdLead Sponsor
10 Previous Clinical Trials
700 Total Patients Enrolled
2 Trials studying Prostate Cancer
413 Patients Enrolled for Prostate Cancer
Clarity PharmaceuticalsStudy DirectorClarity Pharmaceuticals
2 Previous Clinical Trials
427 Total Patients Enrolled
1 Trials studying Prostate Cancer
383 Patients Enrolled for Prostate Cancer

Media Library

64Cu-SAR-BBN (Radiotherapeutic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05633160 — Phase 1 & 2
Prostate Cancer Research Study Groups: 67Cu-SAR-BBN
Prostate Cancer Clinical Trial 2023: 64Cu-SAR-BBN Highlights & Side Effects. Trial Name: NCT05633160 — Phase 1 & 2
64Cu-SAR-BBN (Radiotherapeutic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05633160 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

Who else is applying?

What state do they live in?
What site did they apply to?
GU Research Network
What portion of applicants met pre-screening criteria?
Did not meet criteria
~25 spots leftby May 2026