Study on SX-682 and Enzalutamide for Men with Advanced Prostate Cancer Resistant to Abiraterone

Sponsor: Syntrix Biosystems, Inc.

Sponsor score: 0
Inactive

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

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.

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