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 given written consent to participate before any study-related activities begin.
• People aged 19 years or older at the time of signing the consent form.
• People who have been diagnosed (confirmed by tissue testing) with a type of cancer called extra-pulmonary neuroendocrine carcinoma (a neuroendocrine cancer that did not start in the lungs) that has come back or stopped responding to treatment. This includes small cell carcinoma, large cell carcinoma, and mixed types. People with prostate cancer that has changed into a neuroendocrine cancer after hormone-blocking treatment may also be eligible.
• People whose cancer originated in the stomach, oesophagus, small intestine, bowel, pancreas, or bile ducts (Cohort 1 — gastrointestinal and pancreaticobiliary group).
• People whose cancer originated in the prostate, bladder, ureter, urethra, or kidney (Cohort 2 — genitourinary group).
• People whose cancer has progressed or returned after at least one platinum-based chemotherapy treatment (a common type of chemotherapy). For prostate cancer patients, this platinum-based treatment does not need to have been the first treatment given.
• People who were previously treated for localised (non-spread) disease and whose cancer has since returned.
• People who received a specific chemotherapy combination (platinum and etoposide) after surgery and whose cancer has since returned.
• People who have measurable disease visible on scans, as defined by standard medical criteria (RECIST 1.1), identified within the 21-day screening period. For prostate cancer patients without measurable disease by those criteria, eligibility may be assessed using a different prostate-specific standard (confirm with trial site).
• People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (ECOG), meaning they are fully active to somewhat limited in physical activity.
• People with a life expectancy of at least 12 weeks.
• People whose blood, kidneys, liver, lungs, and heart are functioning at levels that meet specific minimum thresholds assessed by blood tests and scans (confirm exact values with trial site).
• People who are able to provide a tumour tissue sample (either from a previous biopsy or a new one) for testing.

Who may not be able to join:

• People with active, symptomatic cancer spread to the brain, unless the brain metastases have been treated, are no longer causing symptoms, and meet specific timing and medication requirements (confirm details with trial site).
• People with cancer that has spread to the lining around the brain or spinal cord (leptomeningeal disease).
• People who previously received immune checkpoint inhibitor therapy and experienced severe or life-threatening immune-related side effects, immune-related brain inflammation, recurring lung inflammation (grade 2 or higher), or had to permanently stop immunotherapy due to infusion reactions. (An exception may apply for people with stable hormone-related side effects managed with replacement therapy — confirm with trial site.)
• People with an active autoimmune disease that has required systemic treatment (other than replacement hormone therapy) within the past 2 years, or any condition requiring immune-suppressing medications during the study.
• People who have had a solid organ transplant (such as a kidney, liver, or heart transplant).
• People who have had another cancer within the past 2 years, with some exceptions for certain low-risk, well-treated cancers (confirm with trial site).
• People who have had a heart attack or significant heart failure within the 12 months before starting the study treatment.
• People who have had a stroke or mini-stroke (transient ischaemic attack) within the 12 months before starting the study treatment.
• People with active, uncontrolled HIV infection. (People with HIV on antiviral treatment with undetectable virus levels may be eligible, with ongoing monitoring — confirm with trial site.)
• People with active hepatitis C infection with detectable virus in the blood. (People with past hepatitis C and no detectable virus may be eligible — confirm with trial site.)
• People with active hepatitis B infection with detectable virus in the blood. (People with resolved or inactive hepatitis B infection may be eligible with regular monitoring — confirm with trial site.)
• People currently taking immune-suppressing medications or corticosteroids (such as prednisone above a low dose) within 7 days before starting treatment, with some exceptions for low-dose steroids and anti-nausea medications.
• People with signs or symptoms of an uncontrolled active infection within 7 days before starting treatment.
• People with lung inflammation (pneumonitis) or interstitial lung disease.
• People who have previously received the study drug tarlatamab, or any other treatment that targets the same pathway (DLL3 pathway).
• People who have already received more than 2 prior systemic treatment courses for this type of cancer. (For prostate cancer patients, certain earlier hormone or chemotherapy treatments may not count toward this limit — confirm with trial site.)
• People who received cancer treatment less than 21 days before starting the study (shorter periods may be acceptable for some chemotherapy or radiotherapy — confirm with trial site).
• People currently receiving other anti-cancer treatments such as chemotherapy, immunotherapy, or targeted therapy, with limited exceptions (confirm with trial site).
• People who have taken certain herbal or prescription medications that affect specific liver enzymes (CYP3A) or drug transport proteins (P-gp, BCRP) within a specified period before starting the study (confirm specific medications and timeframes with trial site).
• People who have already received the maximum safe dose of certain heart-toxic drugs (such as anthracyclines).
• People who have had major surgery within 28 days before starting the study treatment.
• People who have received a live vaccine within 14 days, or certain other vaccines within 3 days, before starting the study treatment.
• People currently participating in another clinical trial, or who have finished one less than 30 days ago.
• People who are pregnant, breastfeeding, planning to become pregnant, or planning to donate eggs during the study or within 60 days after the last dose of study treatment.
• People with a positive pregnancy test at screening.
• Male participants unwilling to use contraception or abstain from sexual activity, or unwilling to avoid donating sperm, during the study and for 60 days after the last dose of treatment.
• Male participants with a pregnant partner who are unwilling to abstain or use a condom during the study and for 60 days after the last dose.
• People with a known allergy or sensitivity to any component of the study treatment.
• People who are unlikely to be able to attend all required study visits or follow all study procedures.
• People with any other significant medical condition or disorder that the trial site considers would affect participation (confirm with trial site).

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