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Radiotherapeutic Agent
SAR-BBN Radiotracers for Prostate Cancer (COMBAT Trial)
Phase 1 & 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreTrial 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
64Cu-SAR-BBN
2022
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
Clarity Pharmaceuticals LtdLead Sponsor
10 Previous Clinical Trials
703 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with a blood clot in my leg or lung in the last 4 weeks.My prostate cancer is of the small cell type.I have ongoing pancreatitis.I have brain metastasis causing symptoms.I am scheduled for external beam radiation therapy after joining the study.My prostate cancer diagnosis was confirmed through lab tests.I have cancer spread to my spine causing or threatening to cause spinal cord pressure.I have at least one cancer spread that shows on recent scans.My testosterone levels are very low (<50 ng/dL or <1.7 nmol/L).I am 18 years old or older.My scans show my cancer is growing and does not have a certain protein.I can take care of myself and am up and about more than half of my waking hours.I do not have any condition that would make radiation unsafe for me or my caregiver.My PET/CT scan shows a lesion larger than my liver's uptake.I have had leukemia or Myelodysplastic Syndrome in the past.I have not received a transfusion just to qualify for this study.I have not had major surgery in the last 3 months.I have been cancer-free for over 3 years, except for non-melanoma skin cancer or superficial bladder cancer.I haven't had cancer treatments like chemotherapy or immunotherapy in the last 4 weeks.I have a severe blockage in my urinary tract that can't be easily treated.I haven't had certain radioactive treatments in the last 3 to 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: 67Cu-SAR-BBN
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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