Phase 2 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 between 18 and 85 years old at the time of signing the consent form (the upper age limit is 80 years during the early dose-finding phase of the trial).
• People whose general health and ability to carry out daily activities is rated as fully active or restricted only in physically strenuous activity (ECOG performance status 0 or 1).
• People whose life expectancy is at least 12 weeks.
• People with a PSA (prostate-specific antigen) blood level of 1 ng/mL or higher during the screening period.
• People who are receiving ongoing hormone therapy (LHRHa injections) to suppress testosterone, or who have had both testicles surgically removed; those still on hormone therapy must plan to continue it throughout the study.
• People whose prostate cancer has been confirmed by a tissue or cell sample as prostate adenocarcinoma, and who have not been diagnosed with neuroendocrine carcinoma or small cell carcinoma.
• People whose cancer has been confirmed to have spread (metastasised) to other parts of the body, as shown by CT scan, MRI, or bone scan.
• Male participants whose partners could become pregnant must agree to use highly effective contraception from the time of signing the consent form until 5 months after the last dose, and must not donate sperm during this period.

Who may not be able to join:

• People who are planning to receive any other cancer treatment during the study.
• People who have taken another experimental or unapproved drug or treatment within the 4 weeks before starting this trial.
• People who have had surgery requiring general anaesthesia within 28 days before the first dose, minor or diagnostic surgery within 7 days before the first dose, or who have planned elective surgery during the trial period.
• People who have not yet recovered from side effects of previous cancer treatments to a mild or resolved level (with some exceptions, such as mild nerve-related symptoms, hair loss, well-controlled low thyroid function, or well-controlled type 1 diabetes — confirm with trial site).
• People with a known allergy or sensitivity to the study drug or any of its ingredients.
• People with cancer that has spread to the brain or spinal cord that has not been treated or is not well controlled; people whose brain or spinal cord metastases have been treated and whose symptoms have been stable for at least 4 weeks before joining may still be considered eligible (confirm with trial site).
• People who have cancer pain that is not adequately controlled, or who are not yet on a stable pain medication routine.
• People with fluid build-up in the chest, around the heart, or in the abdomen that cannot be controlled, or that keeps coming back quickly after being drained, requiring repeated drainage procedures.
• People who have had another cancer in the past 5 years, with the exception of certain skin cancers, a type of thyroid cancer, or a non-invasive breast condition that has been fully treated.
• People who have had epilepsy (seizures) or certain conditions that increase the risk of seizures — such as a mini-stroke, stroke, or a head injury with loss of consciousness requiring hospitalisation — within the past 12 months.
• People with a history of serious lung inflammation or scarring conditions (such as interstitial lung disease, pulmonary fibrosis, or drug- or radiation-related lung inflammation), or who show signs of active pneumonia on a chest CT scan.
• People with serious active digestive system problems, such as bowel obstruction, ongoing or recurring diarrhoea, significant gastrointestinal bleeding, stomach ulcers, bowel perforation, acute pancreatitis, ulcerative colitis, Crohn's disease, or similar conditions.
• People who have had a severe infection within 4 weeks before the first dose, an active infection requiring antibiotic treatment within 2 weeks before the first dose, or evidence of active tuberculosis within the past year; people with a past history of tuberculosis that was not properly treated are also excluded.
• People with active hepatitis B or hepatitis C infection, as determined by specific blood test results.
• People with a history of immune system deficiency (including HIV), other inherited or acquired immune conditions, organ transplantation, or an active autoimmune disease; some exceptions may apply for mild immune conditions not needing systemic treatment or those well controlled by hormone replacement (confirm with trial site).
• People with a history of serious heart or stroke-related disease.
• People who have had a blood clot in an artery or vein within the 3 months before the first dose, or in whom a blood clot is found during the screening period.
• People with any other illness, medical condition, or personal circumstance that the trial doctor believes could affect safety or interfere with completing the study.

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