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 give signed consent and are willing to follow the study rules and schedule.
• People who are willing to sign a separate consent form related to optional genetic research.
• People who are 18 years of age or older at the time of signing the consent form.
• People who have a confirmed diagnosis of prostate cancer that has spread to other parts of the body (metastatic adenocarcinoma).
• People whose testosterone levels have been reduced to very low levels through surgery or ongoing hormone-blocking medication, with levels confirmed within 28 days before the first treatment dose.
• People whose prostate cancer has continued to grow or spread despite having testosterone reduced to very low levels (this is known as castration-resistant prostate cancer).
• People with a PSA level of at least 1 ng/mL at the screening visit (PSA is a protein measured through a blood test that can indicate prostate cancer activity).
• People who are able to provide a tumor tissue sample, either recently collected or stored from a previous biopsy.
• People whose cancer has shown signs of getting worse within the 6 months before screening, shown by rising PSA levels on at least 3 tests, or by imaging showing the cancer has grown in soft tissue or bone.
• People who meet the specific prior treatment requirements for the relevant part and module of the study, as set out in the study protocol (confirm with trial site).
• People with an ECOG performance score of 0 or 1, meaning they are either fully active or have only minor limitations in physical activity.
• People with a life expectancy of more than 12 weeks.
• People with adequate blood, kidney, bone marrow, and liver function, as defined in the study protocol.
• People who weigh at least 35 kg.
• People who were male at birth, inclusive of all gender identities.
• People, or their partners, who are willing to use contraception as outlined in the study protocol and consistent with local guidelines.

Who may not be able to join:

• People with severe or uncontrolled serious illnesses that the study doctor believes would make participation unsuitable.
• People with certain heart rhythm abnormalities, including a corrected QT interval greater than 470 ms on a resting heart tracing, a history of heart rhythm problems caused by medications, a condition called long QT syndrome (inherited or family history), or unexplained sudden death in a close family member before the age of 40.
• People with certain types of irregular heartbeats that cause symptoms or require treatment (unless controlled by a pacemaker), or uncontrolled irregular heart rhythms.
• People with a history of another cancer, unless that cancer was treated with the intention to cure, has shown no signs of returning for at least 2 years, and carries a low risk of coming back.
• People with a history of, or plans to have, an organ transplant or stem cell transplant from a donor.
• People who still have significant side effects (grade 2 or higher) from previous cancer treatments that have not yet resolved (some exceptions may apply — confirm with trial site).
• People who have previously experienced serious immune-related reactions (grade 3 or higher cytokine release syndrome, or grade 2 or higher immune-related brain effects) from prior treatments.
• People with a history of a serious immune system condition called hemophagocytic lymphohistiocytosis or macrophage activation syndrome.
• People with active or recent autoimmune or inflammatory conditions within the past 3 years, or conditions requiring long-term immune-suppressing treatment.
• People with spinal cord compression, unless it has been treated, is stable, causes no symptoms, and does not require ongoing steroid medication above a low dose.
• People with certain brain or nervous system conditions, as specified in the study protocol (confirm with trial site).
• People with active or uncontrolled hepatitis B or C infection (some exceptions may apply — confirm with trial site).
• People with HIV that is not well controlled, as defined in the study protocol (confirm with trial site).
• People who have had radiation therapy within 4 weeks before the first dose (or local/targeted radiotherapy within 2 weeks).
• People who do not meet the prior treatment requirements set out in the study protocol (confirm with trial site).
• People taking steroid medication at a dose higher than 10 mg per day of prednisone (or equivalent) within 7 days before the first dose.
• People who have had major surgery or a significant injury within 4 weeks before the first dose.
• People who have recently received another cancer treatment or participated in another clinical trial within 21 days or 5 half-lives of the drug (whichever is shorter), or who have received CAR-T cell therapy within the past 6 months.
• People with a known allergy or sensitivity to the study drug AZD6621 or any of its ingredients.
• People who are involved in planning or running this study.
• People who are unlikely to be able to follow the study procedures and requirements, as assessed by the study doctor.
• People who have received a live vaccine within 30 days before the first dose, or a COVID-19 vaccine within 72 hours before the first dose.
• People who have previously taken part in this same study.

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