Phase 1 Prostate Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are male and aged 18 years or older
• People whose general health and ability to carry out daily activities meets a certain standard, and who are expected to live for at least 3 months (confirm with trial site)
• People whose prostate cancer has been confirmed by tissue or cell testing to be a type called adenocarcinoma
• People whose scans show that cancer has spread to the bones or soft tissues
• People who are currently receiving hormone therapy to lower testosterone (medical castration) or who have previously had surgical removal of the testicles (surgical castration)
• People whose testosterone levels were at castration level at the time of screening
• People whose cancer showed signs of getting worse while they were receiving hormone therapy to lower testosterone
• People whose cancer got worse after at least one newer type of hormone treatment, and after at least one type of chemotherapy containing a drug called a taxane — or people who were unable to tolerate or declined chemotherapy
• People whose major organs (such as liver, kidneys, and bone marrow) are functioning at a level that meets the trial's requirements (confirm with trial site)

Who may not be able to join:

• People with a known allergy or sensitivity to the study drug HSK46575 or any of its ingredients
• People who have received cancer treatment within 4 weeks (or 5 half-lives, whichever is shorter) before starting the trial, or who have received certain specific treatments (nitrosoureas, bicalutamide, or nilutamide) within 6 weeks before starting
• People who still have side effects from previous cancer treatment that are more than mild at the time of starting the trial
• People who have taken certain medications that affect how drugs are processed by the body within 14 days or 5 half-lives before starting the trial (confirm with trial site for specific medications)
• People who have had a major surgical procedure (classified as Grade 3–4 surgery) (confirm with trial site)
• People who plan to receive any other cancer treatment during the study
• People whose cancer has spread to the brain or spinal cord and is currently causing problems
• People with serious damage to their bones caused by cancer spread, as assessed by the treating doctor
• People who had problems with their pituitary or adrenal glands within 6 months before starting the trial
• People with blood pressure that is not well controlled
• People with nervous system conditions such as epilepsy or multiple sclerosis
• People who have had significant heart or blood vessel problems within 6 months before starting the trial, or who have a history of blood clots in the arteries or veins
• People whose heart's electrical activity (measured by an ECG) shows a specific type of abnormality called a prolonged QTc interval above a certain level
• People who have had another type of cancer in the past
• People with a history of immune system deficiency
• People with active infections of hepatitis B, hepatitis C, or syphilis
• People who have taken part in another clinical trial within 4 weeks before starting this trial
• People with other conditions that the trial team determines may affect eligibility (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.