Study to Find the Right Dose of Debio 4228 for Advanced Prostate Cancer

Sponsor: Debiopharm International SA

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06395753

Provider View

This clinical trial is focused on finding the right dose of a new drug, Debio 4228, for patients with advanced prostate cancer. The study will look at how the drug moves through the body and its effects.

Patient Parameters

Program Overview

The main goal of this study is to understand how Debio 4228 behaves in the body and its effects on patients with advanced prostate cancer. Researchers will study how the drug is absorbed, distributed, and eliminated, as well as its impact on the body.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic prostate cancer.
  • Be considered suitable for ongoing hormone therapy to lower testosterone levels.
  • Have a morning testosterone level above 150 ng/dL at the screening visit.
  • Be in good general health with an ECOG performance status of 0 to 2, meaning fully active or able to carry out light work.
  • Have a life expectancy of at least 6 months.
  • Have adequate bone marrow, liver, and kidney function based on tests at the screening visit.

Exclusion Criteria

  • Have previously received hormone therapy for prostate cancer for 6 months or more, with less than a 6-month break before screening.
  • Need combination hormone therapy.
  • Have had surgery to remove the testicles, adrenal glands, or pituitary gland.
  • Have received chemotherapy or cryotherapy for prostate cancer within 8 weeks before screening.
  • Have abnormal heart function or diabetes.
  • Have used testosterone supplements within 6 months before screening.
  • Have had major surgery within 4 weeks before screening.
  • Have had another type of cancer within the last two years, except for prostate cancer and some skin cancers.

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