Study on Tinengotinib Combined with Standard Treatments for Prostate Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06457919

Provider View

This clinical trial is testing whether the drug tinengotinib, when used with standard prostate cancer treatments like abiraterone acetate and prednisone or enzalutamide, is safe and causes only mild side effects in people with advanced prostate cancer that has spread and is resistant to hormone therapy.

Patient Parameters

Program Overview

The purpose of this study is to determine if combining tinengotinib with standard treatments such as abiraterone acetate and prednisone or enzalutamide is a safe and effective option for people with metastatic castration-resistant prostate cancer (mCRPC). Researchers want to see if this combination causes only mild side effects and can be tolerated by patients.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and have signed informed consent.
  • Have a confirmed diagnosis of prostate cancer (some neuroendocrine differentiation is allowed, but not pure small cell carcinoma).
  • Have cancer that has spread, shown by at least 2 bone lesions or soft tissue disease on scans (not just PET scans).
  • Currently taking and tolerating full doses of abiraterone acetate or enzalutamide for at least 90 days before joining the study, with a possible 30-day break allowed.
  • Show signs of disease progression on abiraterone acetate or enzalutamide, such as rising PSA levels, new lesions on bone scans, or tumor growth.
  • Have measurable disease or a PSA level of 2.0 ng/mL or higher at the start of the study.
  • Be undergoing ongoing androgen deprivation therapy (ADT) for at least 90 days or have had both testicles removed.
  • Have an ECOG performance status of 0 to 2, indicating good overall health.
  • Have adequate organ function as shown by specific blood tests.
  • Be willing to undergo a tumor biopsy during screening if it is safe and possible.

Exclusion Criteria

  • Have pure small cell carcinoma.
  • Have previously been treated with multiple tyrosine kinase inhibitors (multi-TKI therapies).
  • Have uncontrolled high blood pressure or heart disease with chest pain.
  • Have a history of heart failure or serious heart rhythm problems, recent heart attack, or specific heart test results.
  • Have another cancer that could interfere with the study.
  • Have untreated or symptomatic cancer spread to the brain.
  • Have a pre-existing duodenal stent or gastrointestinal issues affecting medication absorption.
  • Require high doses of steroids or immunosuppressive medications within 14 days before starting the study.
  • Have had other cancer treatments within 3 weeks before starting the study, except for ongoing androgen deprivation therapy, enzalutamide, or abiraterone acetate.
  • Have had palliative radiation within 2 weeks before starting the study.

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