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 aged 18 or older
• People whose blood oxygen level is 90% or higher while breathing normal room air
• People who have been diagnosed with prostate cancer confirmed by a tissue sample (any type of prostate cancer is accepted)
• People whose cancer has spread to other parts of the body, confirmed by CT scan, MRI, or bone scan taken during the screening period (note: spread detected only on a PET scan does not meet this requirement)
• People whose testosterone level is 50 ng/dL or below while receiving hormone-suppression therapy — or people with a specific aggressive subtype of prostate cancer called "de novo small cell NEPC," for whom testosterone levels and hormone therapy are not required
• People whose cancer has continued to grow or spread after at least one treatment for metastatic prostate cancer, shown by rising PSA levels, growth of tumours on scans, or new spots on a bone scan
• People with the de novo small cell NEPC subtype who have already received platinum-based chemotherapy, or for whom that treatment is not considered suitable by their doctor
• People who have received no more than two prior rounds of chemotherapy for their metastatic castration-resistant prostate cancer or de novo small cell NEPC
• People whose tumour tests positive for a protein called DLL3 (defined as 50% or more of tumour cells showing DLL3 expression on a lab-certified test), confirmed by a tissue sample taken at any point before joining the study
• People who have cancer that has spread to the brain, provided that treatment for those brain lesions was completed at least two weeks before the study starts, no steroids are being used for brain-related symptoms, and brain scans taken during screening show no new growth after treatment
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (ECOG scale), meaning people who are fully active, have some limitations but can care for themselves, or are up and about more than half of the day
• People whose blood counts and organ function (kidneys, liver, and blood cells) fall within the acceptable ranges specified by the trial, based on tests taken within 14 days of starting treatment
• People who agree to use an acceptable form of contraception (such as condoms with spermicide) or remain sexually abstinent throughout the study and for 60 days after the last dose, and who agree not to donate sperm during this period; female partners must also use hormonal or barrier contraception unless they are postmenopausal or abstinent
• People who are willing and able to provide written consent to participate, or who have a legal representative who can do so on their behalf

Who may not be able to join:

• People who have or have had another cancer that could interfere with the safety or results of this trial, in the opinion of the trial doctor
• People with uncontrolled high blood pressure, any history of seizures, a heart attack or stroke within the past 6 months, severe heart failure, or an uncontrolled irregular heartbeat
• People with an active hepatitis B or hepatitis C infection (previous treated hepatitis B or C is generally acceptable — confirm with trial site)
• People with an active HIV infection where the virus is still detectable in the blood despite antiviral treatment
• People who have had cancer spread to the thin layers of tissue surrounding the brain and spinal cord (leptomeningeal disease)
• People with an active autoimmune disease that has required systemic treatment in the past 2 years, or who experienced a significant autoimmune side effect (above a certain severity level) from a prior immune therapy — with some exceptions for certain hormone-related conditions managed with replacement treatment (confirm with trial site)
• People with a history of a lung condition called interstitial lung disease, or who currently have a lung inflammation (pneumonitis) of moderate severity or above
• People diagnosed with an immune deficiency condition, or who have been taking steroid medications above a low daily dose within 7 days of starting the study
• People who have an active infection that requires antibiotics given through a drip or injection within 7 days of starting the study
• People who have previously received any treatment that specifically targets the DLL3 protein
• People who have received other cancer treatments (apart from certain hormone injections) within 14 days or within 5 half-lives of the treatment, whichever is shorter, before starting the study
• People who have taken part in another clinical trial with an experimental treatment within 14 days or 5 half-lives, whichever is shorter, before starting the study
• People who have undergone a major surgical procedure within 28 days before starting the study
• People who have received radiotherapy for pain relief less than 1 week before starting the study
• People taking certain medications that may interact with the study drug within two weeks before starting the study (the specific list is detailed in the trial documents — confirm with trial site)
• People who are still experiencing side effects above a moderate level from a previous cancer treatment at the time of starting the study
• People with a known allergy to any of the substances being studied in this trial
• People who have any other condition that, in the trial doctor's judgement, would make participation unsuitable

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