Phase 1 Bladder 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:

• People who have been diagnosed with muscle-invasive bladder cancer (a cancer that has grown into the muscle wall of the bladder), confirmed by a tissue or cell sample, at a stage where it has not spread to distant parts of the body (note: tumours with a small cell or neuroendocrine component are not eligible).
• People who have not previously received chemotherapy delivered through the bloodstream for this bladder cancer, and who have either declined standard chemotherapy given alongside radiation, are not considered suitable for bladder removal surgery, or have declined that surgery.
• People who are generally well enough to carry out basic daily activities, as measured by a standard medical scale (ECOG score of 2 or lower).
• People whose blood test results show that the liver, kidneys, and blood cells are functioning within acceptable ranges as defined by the trial (confirm specific values with trial site).
• People whose bladder is functioning well enough that bladder preservation is considered a reasonable option by their treating doctor, including those without blockage of both kidneys caused by the tumour (blockage of one kidney is permitted).
• People who have had a procedure to remove as much of the bladder tumour as possible (called a TURBT) within the 60 days before treatment starts.
• People whose tumour was fully or partially removed during TURBT, as long as the surgeon aimed to remove as much as possible.
• People who have had imaging scans (CT or MRI) of the chest, abdomen, and pelvis within 60 days before treatment starts, confirming the cancer has not spread beyond certain boundaries as assessed by the trial site's radiology team.
• People who have not had a urothelial (bladder-lining) cancer in any location outside the bladder in the past 24 months, with one exception: early-stage cancer in the upper urinary tract (kidney, pelvis, or ureter) may be acceptable if the affected kidney and ureter were completely removed.
• People who are able to understand the study and are willing to sign a consent form.

Who may not be able to join:

• People who are currently taking part in another clinical trial or using another experimental treatment or device.
• People who have previously had radiation therapy to the pelvis or lower abdomen for any reason.
• People who have previously received any systemic (whole-body) treatment, combined chemotherapy and radiation, or radiation alone for bladder cancer at any stage (note: prior treatment placed directly into the bladder, such as BCG or bladder-instilled chemotherapy, is generally permitted).
• People who have been diagnosed with blockage of both kidneys caused by the bladder tumour.
• People who have significantly reduced bladder function, such as frequently passing only small amounts of urine, urinary leakage, or needing a catheter to empty the bladder.
• People who have had a serious allergic reaction to the study drug (Sacituzumab Govitecan) or to similar medicines.
• People with serious ongoing health conditions that are not well controlled, such as active infection, heart failure, unstable chest pain, irregular heart rhythm, or mental health or social circumstances that would make it difficult to follow the study requirements.
• People who are pregnant or breastfeeding, due to potential risks to the baby from the study drug and radiation.
• People who have used an experimental treatment or device within 4 weeks before the first dose of the study drug (those in a follow-up phase of a previous trial may be eligible if it has been at least 4 weeks since their last dose of that experimental treatment).
• People whose medical history, current health condition, or test results could interfere with the study results or their ability to complete the full study, in the opinion of the treating doctor.

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