Study on SX-682 and Enzalutamide for Men with Advanced Prostate Cancer Resistant to Abiraterone
Sponsor: Syntrix Biosystems, Inc.
Sponsor score: 0
ClinicalTrials ID:NCT06228053
This clinical trial is exploring a new treatment combination of SX-682 and enzalutamide for men with advanced prostate cancer that has spread and is no longer responding to abiraterone.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to test the effectiveness of combining two drugs, SX-682 and enzalutamide, in treating men with metastatic castration-resistant prostate cancer (mCRPC) who have not responded to abiraterone treatment. The study aims to see if this combination can help control the cancer.
Eligibility Criteria
Inclusion Criteria
- Must have signed a consent form approved by an ethics committee before starting the study.
- Diagnosed with metastatic castration-resistant prostate cancer (mCRPC) and have been treated with abiraterone and prednisone.
- Show signs of cancer progression, such as rising PSA levels or new or growing tumors.
- Have tumor tissue available for future studies.
- Have low testosterone levels or be on ongoing androgen deprivation therapy (ADT).
- Have a performance status score of 70 or higher, indicating the ability to care for oneself.
- Be 18 years or older.
- Have a life expectancy of at least 6 months.
- Have recovered from previous treatments to a certain level of health.
- Have adequate bone marrow, liver, and kidney function based on specific blood tests.
- Agree to use effective birth control during the study and for 90 days after the last dose if not surgically sterile or if partners are not postmenopausal.
- Willing to provide written consent and authorization for the release of personal health information.
Exclusion Criteria
- Have had certain cancer treatments recently, such as docetaxel, radium-223, or PSMA-Lu177-617.
- Have taken ketoconazole or other specific cancer drugs, or have had multiple chemotherapy regimens.
- Have liver metastases visible on imaging tests.
- Have had recent radiotherapy or major surgery.
- Have received a live vaccine recently.
- Are participating in another clinical trial or have used an investigational device recently.
- Have an immune deficiency or are on high-dose steroids or other immunosuppressive therapy.
- Have serious heart conditions or uncontrolled high blood pressure.
- Have a history of another cancer unless treated and cancer-free for 2 years.
- Have untreated brain metastases or certain brain conditions.
- Have active autoimmune diseases requiring treatment in the past 2 years.
- Have a history of lung inflammation requiring steroids.
- Have an active infection needing treatment.
- Have uncontrolled HIV, Hepatitis B, Hepatitis C, or TB infections.
- Have any condition that could interfere with the study or is not in the best interest of the participant.
- Have psychiatric or substance abuse issues affecting study participation.
- Have had an organ transplant.
- Are taking medications that affect the heart's rhythm or certain liver enzymes, unless essential for care.
- Have a heart condition affecting the QT interval or have had recent heart surgery or events.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, Los Angeles | 90095 | Los Angeles | California |
| University of California, San Francisco | 94143 | San Francisco | California |
| University of Michigan | 48109 | Ann Arbor | Michigan |
| University of Minnesota | 55455 | Minneapolis | Minnesota |
| Duke University | 27710 | Durham | North Carolina |
| University of Wisconsin | 53792 | Madison | Wisconsin |
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