Study on FPI-2265 for Patients with PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
Sponsor: Fusion Pharmaceuticals Inc.
ClinicalTrials ID:NCT06402331
This clinical trial is testing a new treatment called FPI-2265 for men with advanced prostate cancer that has spread and is resistant to hormone therapy. The study aims to find the best dose and schedule for this treatment in patients who have already received a similar type of therapy.
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Program Overview
The study is exploring the safety and effectiveness of different doses of FPI-2265, a new treatment for prostate cancer that has spread and is resistant to hormone therapy. Participants will be divided into three groups, each receiving different doses of the treatment at varying intervals. The goal is to determine the best dose and schedule for FPI-2265 based on how well it works and how well patients tolerate it.
Description
In this study, researchers are testing a new treatment called FPI-2265 for men with advanced prostate cancer that has spread and is resistant to hormone therapy. The study is in Phase 2, which means it is focused on finding the best dose and schedule for the treatment. Participants will be randomly assigned to one of three groups:
- Group 1 will receive nine doses of FPI-2265 every four weeks.
- Group 2 will receive six doses every six weeks.
- Group 3 will receive four doses every eight weeks.
The study will monitor participants to see how well the treatment works, if the cancer progresses, and if there are any side effects. The goal is to find the most effective and safest way to use FPI-2265 for treating this type of prostate cancer.
Eligibility Criteria
Inclusion Criteria
- Must be able to understand and sign a consent form and follow study requirements.
- Must have a good performance status (ECOG 0 or 1).
- Must have a confirmed diagnosis of prostate cancer.
- Must have had surgery to remove the testicles or be on hormone therapy with low testosterone levels.
- Must have advanced prostate cancer that is progressing.
- Must have previously received lutetium-PSMA therapy, completed at least six weeks before starting the study.
- Participants with BRCA mutations should have tried FDA-approved therapies like PARP inhibitors.
- Must have a positive PSMA PET/CT scan.
- Must have adequate organ function.
- If participants or their partners can have children, they must agree to use effective birth control during the study and for six months after the last dose.
Exclusion Criteria
- Cannot have received more than two previous chemotherapy treatments for prostate cancer.
- Cannot have cancer that progressed within two cycles of previous lutetium-PSMA therapy.
- Must have resolved any previous treatment side effects to a mild level, except for hair loss or stable mild nerve damage.
- Cannot have unresolved urinary tract blockages.
- Cannot have received any other cancer treatments within 30 days before starting the study.
- Cannot have a history of brain metastases unless treated.
- Cannot have liver metastases for Phase 2 of the study.
- Cannot have extensive bone metastases as shown on a specific bone scan.
- Cannot have another type of cancer unless it was treated over two years ago or is a non-threatening type like certain skin cancers.
- Cannot have serious medical conditions as determined by the study doctor.
- Cannot have had major surgery within 30 days before starting the study.
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