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 have had their prostate cancer confirmed as adenocarcinoma (a specific type of prostate cancer) through a tissue or cell sample from all previous biopsies.
• People with tumours in soft tissue who have an accessible lesion must agree to a biopsy during the screening period, or be able to provide a previously taken (archival) tissue sample from a primary or spread tumour.
• People whose testosterone levels are below 50 ng/dL at the time of screening.
• People who have received no more than one prior treatment with a second-generation hormone-blocking drug (such as abiraterone acetate, enzalutamide, apalutamide, or darolutamide), whether given before or after the cancer became resistant to standard hormone therapy.
• People whose metastatic castration-resistant prostate cancer (prostate cancer that has spread and is no longer responding to standard hormone-lowering treatment) has continued to worsen after their most recent treatment.
• People who have at least one area of cancer spread that can be seen on a CT scan, MRI, or bone scan taken within 28 days before the randomisation date.
• People who have adequate functioning of key organs (such as the liver, kidneys, and bone marrow) at the time of screening.

Who may not be able to join:

• People who have previously received any treatment that targets a protein called CD46.
• People who have a type of prostate cancer called small cell neuroendocrine carcinoma (either on its own or mixed with other cancer types) found in any previous biopsy.
• People who have received more than one prior second-generation hormone-blocking drug (ARSI) in sequence, or more than two different second-generation ARSIs in total.
• People who have received recent anticancer treatments close to the time of enrolment (ongoing hormonal or supportive therapies that were started well before the randomisation date and remain unchanged may be permitted — confirm with trial site).
• People who have had any radiation therapy within 14 days before the randomisation date.
• People who have a known genetic mutation (for example, a BRCA1 mutation) for which approved treatments (for example, PARP inhibitors) are available, unless the treating doctor determines those treatments are not appropriate or the person declines them.
• People who have moderate or severe peripheral neuropathy (nerve damage causing symptoms such as numbness or tingling, rated Grade 2 or higher) at the time of screening, from any cause.
• People who have previously received chemotherapy, except for one prior taxane-based chemotherapy course given before the cancer became resistant to hormone therapy, provided it was completed more than 12 months before randomisation.
• People who have a known serious allergy or hypersensitivity to the study drug FG-3246 or similar substances, or a history of severe allergic reactions to monoclonal antibody treatments.
• People who have been diagnosed with another cancer in the past 5 years, except for certain treated skin cancers (basal cell or squamous cell carcinoma of the skin).
• People who require ongoing treatment with certain strong medications that significantly affect how the body processes drugs (strong CYP3A4 inhibitors or inducers), if those medications cannot be safely stopped.

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