Phase 1 Brain 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:

• Adults aged 18 or older.
• People with a confirmed advanced or spreading solid tumour (not melanoma) that has a TP53 gene mutation or loss, and whose cancer has come back or stopped responding to at least one previous systemic treatment.
• People with prostate cancer that has spread and is no longer responding to hormone therapy (mCRPC), confirmed as a specific type called adenocarcinoma, with a PSA level of at least 2 ng/mL, testosterone below 50 ng/dL through surgery or medication, and who have already tried at least one hormone-targeting drug or chemotherapy such as docetaxel.
• People with solid tumours (not melanoma) that have spread to the brain, where the brain tumours are not immediately requiring urgent local treatment, and where at least one brain tumour measures between 0.5 cm and 3.0 cm.
• People who have had a specific type of targeted radiation to the brain (SRS radiosurgery), completed within 7 days before starting the study, may be considered (confirm with trial site).
• People whose cancer can be measured on scans according to standard criteria (RECIST v1.1).
• People whose bone marrow, heart, liver, and kidneys are functioning at adequate levels, based on specific blood test results (confirm with trial site for exact values).
• Women of childbearing potential who have a negative pregnancy test and agree to use an approved form of contraception during the study and for 3 months after the last dose.
• Men who are sterilised or agree to use barrier contraception (such as condoms with spermicide) during the study and for 3 months after the last dose.
• People with a life expectancy of at least 3 months.
• People who are well enough to carry out basic daily activities, based on a standard health performance scale score of 0 or 1 (ECOG status).
• People who are able to give written informed consent.

Who may not be able to join:

• People with brain metastases that are causing symptoms and need immediate treatment, or cancer that has spread to the lining of the brain or spinal cord.
• People who have had another cancer in the past 3 years, other than certain treated skin cancers or early-stage cancers that have been fully cured.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen.
• People who cannot swallow or absorb oral (tablet/capsule) medication due to gut or digestive conditions, including certain past surgeries such as gastric bypass.
• People who are pregnant or breastfeeding, or people who could become pregnant and are not using adequate contraception.
• People with active HIV, hepatitis B, or hepatitis C infection (people with fully cured hepatitis B or C, or those with well-controlled HIV on effective treatment with no detectable virus in the past 6 months, may still be considered — confirm with trial site).
• People with serious ongoing health conditions that the trial doctor considers incompatible with taking part, such as uncontrolled heart failure or active serious infection.
• People who have had radiation treatment covering more than 30% of their bone marrow within the 3 months before joining.
• People with significant autoimmune disease that is currently active or was present within the past 2 years, or who require immune-suppressing medication at doses above the equivalent of 10 mg of prednisone daily (inhaled or topical treatments may be allowed — confirm with trial site).
• People with certain abnormal heart rhythm findings on an ECG, including a specific measurement (QTcF) above 470 milliseconds.
• People who have received systemic cancer treatment within 3 weeks, or within 5 half-lives of the drug (whichever is the shorter period).
• People who have not yet recovered from side effects of previous cancer treatments to an acceptable level.
• People who have taken certain medications that strongly affect how the body processes drugs (CYP3A4 inhibitors or inducers) within 14 days or 5 half-lives before starting the study treatment (confirm with trial site for specific medications).

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