Phase 2 Bladder 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 who have been diagnosed through a tissue biopsy with a type of bladder cancer called non-muscle-invasive urothelial cell carcinoma (a cancer that has not grown deep into the bladder wall)
• People whose cancer is classified as "very high risk," meaning it meets at least one of these features: multiple or large tumours (over 3 cm) of a high-grade type; high-grade tumour alongside a type called carcinoma in situ (CIS); high-grade tumour with CIS in a nearby area called the prostatic urethra; or a specific rare variant called micropapillary carcinoma
• People whose tumour tissue shows a protein called HER2 (confirmed by a specific laboratory test called IHC showing a result of 1+, 2+, or 3+)
• People who have had all visible tumours removed as completely as possible before starting the trial (note: CIS does not need to be fully removed, but any accompanying papillary tumours do)
• People who are able to receive the first dose of the study drug within 12 weeks of their initial bladder tumour removal procedure (TURBT)
• People who have declined or are considered medically unsuitable for bladder removal surgery
• People whose general health and ability to carry out daily activities is rated at 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
• People whose kidneys are functioning well enough, with a specific kidney function measurement of at least 30 mL/min (calculated using a standard formula)
• People (or their legal representatives) who are willing and able to sign a consent form agreeing to take part
• Women who could potentially become pregnant must have a negative pregnancy test (blood or urine) within 7 days before the first dose of the study drug

Who may not be able to join:

• People whose bladder cancer has spread into the muscle wall, surrounding tissues, or other parts of the body
• People with cancer in the upper urinary tract (kidneys or ureters), unless that cancer was treated more than 2 years ago with no return since then
• People whose biopsy results show certain other cancer types in the bladder, including small cell cancer, pure glandular cancer, or pure squamous cell cancer
• People who have previously received any treatment that targets the HER2 protein
• People who have another active cancer (other than the bladder cancer being treated) that has progressed or required a change in treatment within the past 24 months — with some exceptions, including: skin cancer fully cured within the last 24 months; certain non-invasive breast conditions that have been adequately treated; or a history of early localised breast or prostate cancer currently being managed with specific hormone-based therapies
• People with serious uncontrolled heart or blood vessel conditions, including: a heart attack, unstable chest pain, certain dangerous heart rhythm problems, heart failure (of a serious grade), stroke, or mini-stroke within the past 3 months; an abnormal heart reading on an ECG during screening (a specific electrical measurement above 480 ms); or a blood clot in the lungs or veins within the past 2 months
• Women who are pregnant or breastfeeding
• People with HIV, unless they have been on stable HIV treatment for at least 6 months, have had no serious infections in the past 6 months, and have a recent immune cell count above 350
• People with signs of active hepatitis B or hepatitis C infection (confirm with trial site for specific exceptions)
• People who have not yet recovered from side effects of previous cancer treatments (minor lasting effects such as hair loss or skin colour changes may be acceptable — confirm with trial site)
• People with wounds or ulcers that are not healing properly, including skin ulcers, pressure sores, long-term leg ulcers, known stomach ulcers, or surgical wounds that have not healed
• People who have had major surgery within 4 weeks before the trial starts (note: bladder tumour removal surgery is not counted as major surgery for this purpose)
• People who the trial doctor considers unsuitable for participation for any other reason

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