Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from the 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 18 years of age or older at the time of signing the consent form
• People who have been diagnosed with a specific type of prostate cancer called AVPC or NEPC, based on recent tissue testing and/or clinical assessment
• People who have previously received one or two second-generation hormone-blocking therapies for prostate cancer; prior use of a chemotherapy called docetaxel for castration-resistant prostate cancer is also allowed, but other chemotherapy types are not
• People whose prostate cancer has shown signs of getting worse within the 6 months before screening, confirmed by the doctor through rising PSA blood test levels, new or growing soft tissue tumours on imaging, or two or more new bone spots on a bone scan
• People who have not had surgical removal of the testes and who are currently using, and willing to continue using, a hormone-suppressing injection (LHRH agonist) throughout the study
• People who have at least one tumour that can be measured on a scan according to standard imaging rules (called RECIST v1.1); previously treated areas and people with only skin or bone lesions are not eligible under this criterion
• People with a physical fitness score of 0 or 1 on a standard medical scale (ECOG), assessed within 7 days before starting treatment — meaning they are fully active or have only minor limitations on physical activity
• People with an expected survival of at least 12 weeks
• People with blood, liver, kidney, and clotting function results within the ranges required by the trial, without having needed a blood transfusion or certain blood-boosting treatments in the 2 weeks before starting
• People whose partners could become pregnant must agree to use effective contraception from signing the consent form until 6 months after the last dose
• People who are willing to join the study, sign a consent form, and attend all required visits and follow the study procedures

Who may not be able to join:

• People who have previously received any treatment targeting a protein called TROP2, any drug or antibody-drug combination targeting an enzyme called topoisomerase I (including certain antibody-drug conjugates), or any immune checkpoint therapy (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 drugs), immune cell therapy, or similar immune-based treatments
• People who need to take strong medications that significantly affect how the body processes certain drugs (specifically strong inhibitors or inducers of a liver enzyme called CYP3A4) within 2 weeks before starting or during the study
• People with known spread of cancer to the brain or spinal cord that is active or untreated; people with previously treated brain metastases may be considered if their condition has been stable for at least 4 weeks and they have not needed steroids or anti-seizure medication for at least 14 days (confirm with trial site)
• People diagnosed with another cancer within the 3 years before starting, except for certain locally treated skin cancers or early-stage cervical conditions that are considered cured
• People who have had serious heart or blood vessel problems in the past 6 months, such as a heart attack, unstable chest pain, severe heart failure, stroke, or serious irregular heartbeat; or who have a history of heart muscle disease; or who have had a serious blood clot event (such as a blood clot in the lungs or deep veins) within the past 3 months; or who have had a major blood vessel condition requiring surgery within 6 months
• People with uncontrolled diabetes (with consistently high fasting blood sugar), poorly controlled high blood pressure, or significant fluid build-up around the lungs, heart, or abdomen that causes symptoms or needs to be drained more than once a week
• People with a history of, current, or suspected lung inflammation or scarring of the lungs (called interstitial lung disease or non-infectious pneumonitis) that has required steroid treatment, or that cannot be ruled out on scans during screening
• People with serious existing lung conditions, such as severe asthma, severe chronic obstructive lung disease, a blood clot in the lungs within the past 3 months, restricted lung function, or autoimmune or inflammatory conditions that affect the lungs (such as rheumatoid arthritis, Sjogren's syndrome, or sarcoidosis); or people who have had a whole lung removed
• People with active inflammatory bowel disease, a blocked bowel, serious ulcers, a hole in the bowel, an abdominal abscess, or active bleeding in the digestive tract
• People with a tendency to bleed, ongoing bleeding disorders, or problems with blood clotting
• People whose side effects from previous cancer treatments have not improved to a mild level (grade 1 or lower on a standard medical scale), with some exceptions such as hair loss or fatigue
• People who have an active autoimmune disease requiring ongoing systemic treatment within the past 2 years (such as autoimmune hepatitis, vasculitis, or certain thyroid, kidney, or bowel conditions), or who have taken high-dose steroids or immune-suppressing drugs within 2 weeks before starting; standard hormone replacement therapy is not considered a reason for exclusion (confirm with trial site)
• People with known active tuberculosis, or those suspected of having it who have not been cleared after clinical assessment
• People who have had an organ transplant or bone marrow/stem cell transplant from another person
• People with moderate or severe nerve damage in the hands or feet (grade 2 or higher peripheral neuropathy)
• People with active hepatitis B (with virus levels above a certain threshold) or active hepatitis C; note that people with hepatitis B surface antigen who are positive may still be considered if they receive antiviral treatment during the study (confirm with trial site)
• People who are HIV positive or have a history of AIDS, or who have an active syphilis infection
• People with known allergies to the study drug or its ingredients, or who have had a severe allergic reaction to similar biological medicines
• People who have had major surgery within 4 weeks before starting, or who are expected to have major surgery during the study
• People who have had a serious infection (such as sepsis or severe pneumonia requiring hospitalisation) within 4 weeks before starting, or an active infection requiring treatment within 2 weeks before starting
• People with a history of severe dry eye syndrome, severe eyelid gland disease, or cornea conditions that affect healing
• People who have received certain immune-modifying therapies, traditional herbal medicines with approved anti-cancer uses, or similar treatments within 2 weeks before starting
• People who have received a live vaccine within 30 days before starting, or who plan to receive one during the study; or people whose condition has rapidly worsened during the screening period
• People with serious non-cancer-related conditions, or cancer-related complications, that could increase medical risk or make it difficult to assess survival (such as extreme weight loss or certain blood changes)
• People with any other condition that the trial doctor believes could interfere with the study results, the safety of participants, or how the study drug is assessed

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