Study on FG-3246 for Treating Advanced Prostate Cancer Resistant to Hormone Therapy
Sponsor: FibroGen
Sponsor score: 0
ClinicalTrials ID:NCT06842498
This clinical trial is testing a new drug, FG-3246, to see if it is safe and effective for men with advanced prostate cancer that has not responded to hormone therapy and has not been treated with certain chemotherapy drugs.
Patient Parameters
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Program Overview
The study aims to evaluate the safety and effectiveness of FG-3246, a new drug designed to target a specific protein in prostate cancer cells. This trial is for men with advanced prostate cancer that has continued to grow despite previous hormone therapy and who have not yet received a type of chemotherapy called taxane in this advanced stage.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of prostate cancer.
- Must agree to a biopsy of a tumor if it can be safely accessed, or provide a recent biopsy sample.
- Must have low testosterone levels, or be on medication to keep testosterone low if they haven't had surgery to remove the testicles.
- Must have previously tried one hormone therapy drug like abiraterone or enzalutamide, and the cancer must have continued to grow after this treatment.
- Must have at least one tumor that can be seen on a scan taken within 28 days before starting the study.
- Must have good organ function as shown by medical tests before starting the study.
Exclusion Criteria
- Cannot have been treated with a drug that targets the CD46 protein before.
- Cannot have a type of prostate cancer called small cell neuroendocrine carcinoma.
- Cannot have tried more than one hormone therapy drug in the past.
- Cannot have had any cancer treatments like immunotherapy or radiation within 28 days before starting the study.
- Cannot have certain genetic mutations unless they have already tried and not responded to the specific treatments for those mutations.
- Cannot have had chemotherapy before, except for one specific type if it was completed over a year ago.
- Cannot be allergic to FG-3246 or similar drugs.
- Cannot have had another type of cancer in the last 5 years, except for certain skin cancers.
- Cannot be taking certain medications that affect how the body processes drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Astera Cancer Care | 08816 | East Brunswick | New Jersey |
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