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 able to understand the study information and are willing to sign a consent form before the study begins.
• People aged 18 or older.
• People who have been diagnosed with prostate cancer confirmed by a tissue or cell sample, where the main cancer type found on biopsy is adenocarcinoma (the most common type of prostate cancer).
• People whose cancer has spread (metastatic) and is no longer responding to hormone-lowering treatment — a condition known as metastatic castration-resistant prostate cancer (mCRPC) — confirmed by specific blood tests or imaging scans showing the cancer has grown or spread.
• People whose testosterone levels have been reduced to very low levels, either through ongoing hormone-blocking medication or through surgical removal of the testicles (performed at least 3 months before joining).
• People whose cancer has continued to grow despite treatment with at least one newer type of hormone therapy (such as enzalutamide, abiraterone, darolutamide, apalutamide, or rezvilutamide), or who could not tolerate those treatments.
• People who have received no more than 2 previous rounds of chemotherapy.
• People with a known BRCA1 or BRCA2 gene mutation who have already received a PARP inhibitor treatment, if that treatment was available and tolerable.
• People who have had imaging scans (CT, MRI, or bone scan) within 28 days before starting the trial confirming the cancer has spread.
• People who are able to provide a tumour tissue sample (either a recent or previously stored sample), for testing in a central laboratory.
• People with a general health and activity level rated as fully active or restricted only in physically strenuous activity (ECOG performance status score of 0 or 1).
• People whose blood counts and organ function (including liver, kidneys, and bone marrow) meet the required levels within 7 days before the first dose (confirm with trial site for specific values).
• People who agree to use highly effective contraception from the screening period through to at least 6 months after the last dose.
• People with an expected survival of at least 6 months.
• People who are able and willing to attend all required visits and follow the study procedures.

Who may not be able to join:

• People who have previously been treated with any drug that targets a protein called B7H3.
• People currently taking part in another interventional clinical trial (observational studies or follow-up phases of a previous trial may be acceptable — confirm with trial site).
• People who have previously received a type of chemotherapy called a topoisomerase I inhibitor, or an antibody-drug treatment (ADC) that contains one.
• People whose previous cancer treatment has not had a sufficient break (washout period) before joining (confirm with trial site for specific timeframes).
• People who have recently undergone major surgery (confirm with trial site for specific timeframes).
• People who have previously had a bone marrow transplant from a donor, or a solid organ transplant.
• People who have used steroid (glucocorticoid) medications continuously for more than 28 days within the 28 days before starting the trial.
• People who have received a live vaccine within 4 weeks before the first dose, or who plan to receive one during the study.
• People who have a broken bone caused by cancer spread, or who are considered at high risk of such a fracture.
• People who have cancer that has spread to the membranes surrounding the brain or spinal cord.
• People with uncontrolled blockage of the bladder outlet or urinary incontinence that cannot be managed.
• People who have cancer spread to the brain or compression of the spinal cord.
• People with uncontrolled or clinically significant heart or blood vessel conditions.
• People with significant lung conditions that are causing ongoing problems.
• People diagnosed with Gilbert's syndrome (a liver condition affecting bilirubin processing).
• People with uncontrolled fluid build-up in body cavities (such as the abdomen or chest) that requires repeated draining.
• People with a history of a hole or abnormal opening in the digestive tract within the past 6 months, or with active stomach or bowel ulcers or conditions that may cause bleeding or perforation.
• People who have had a serious active infection within 4 weeks before the first dose.
• People known to have HIV infection.
• People with active hepatitis B or hepatitis C infection.
• People who have been diagnosed with another cancer that could affect life expectancy or make it harder to assess treatment response.
• People who still have unresolved side effects from previous cancer treatments.
• People with a known history of severe allergic reactions to the ingredients in the study drug or to other monoclonal antibody treatments.
• People with any medical condition, mental health condition, or personal circumstances that, in the investigator's view, would prevent safe participation or affect the reliability of study results.

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