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Radioisotope Therapy

FPI-2265 for Metastatic Prostate Cancer (AlphaBreak Trial)

Phase 2 & 3
Recruiting
Research Sponsored by Fusion Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Progressive mCRPC
Diagnosis of adenocarcinoma of prostate proven by histopathology
Must not have
Participants with known, unresolved, urinary tract obstruction are excluded
Participants who received more than two prior lines of cytotoxic chemotherapy for CRPC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose until end of long-term follow-up, 5 years from the last administered dose of fpi-2265.
Awards & highlights

Summary

This trial is testing a new drug called FPI-2265 in patients with prostate cancer that has spread to other parts of the body. They are trying to find the best dose of the drug that

Who is the study for?
This trial is for individuals with metastatic castration-resistant prostate cancer (mCRPC) that shows PSMA positivity. Participants must have previously undergone treatment with a specific type of radioligand therapy using 177Lu-PSMA.
What is being tested?
The study is testing FPI-2265, a new drug targeting PSMA-positive cells in mCRPC patients. It's an open-label and multicenter trial aiming to find the best dose by looking at safety, tolerability, and how well it works against tumors.
What are the potential side effects?
Potential side effects may include typical reactions from radiation-based therapies such as nausea, fatigue, dry mouth or eyes, and decreased blood cell counts leading to increased infection risk or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is worsening despite treatment.
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My prostate cancer was confirmed through a tissue examination.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have undergone treatment to lower my testosterone for prostate cancer.
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I have completed lutetium-PSMA therapy more than 6 weeks ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any ongoing issues with blocked urinary pathways.
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I have had more than two chemotherapy treatments for prostate cancer.
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My cancer got worse within two treatments of 177Lu-PSMA therapy.
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My bone scan shows widespread cancer spread in my bones.
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I haven't had chemotherapy, investigational drugs, or major radiation within the last month.
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I do not have liver metastases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose until end of long-term follow-up, 5 years from the last administered dose of fpi-2265.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose until end of long-term follow-up, 5 years from the last administered dose of fpi-2265. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and proportion of participants with PSA50 response
Frequency, duration, and severity of treatment-emergent adverse events (TEAEs)

Trial Design

3Treatment groups
Experimental Treatment
Group I: FPI-2265 75 kBq/kgExperimental Treatment1 Intervention
Arm 2: FPI-2265 administered by IV injection every six weeks; up to 6 doses.
Group II: FPI-2265 50 kBq/kgExperimental Treatment1 Intervention
Arm 1: FPI-2265 administered by IV injection every four weeks; up to 9 doses.
Group III: FPI-2265 100 kBq/kgExperimental Treatment1 Intervention
Arm 3: FPI-2265 administered by IV injection every eight weeks; up to 4 doses.

Find a Location

Who is running the clinical trial?

Fusion Pharmaceuticals Inc.Lead Sponsor
5 Previous Clinical Trials
526 Total Patients Enrolled
Keith BarnettStudy DirectorFusion Pharmaceuticals Inc.
1 Previous Clinical Trials
115 Total Patients Enrolled
~40 spots leftby Jul 2026
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