Phase 1 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 who have been diagnosed with urothelial carcinoma (a type of bladder or urinary tract cancer), confirmed by a tissue sample. Mixed cell types are allowed as long as urothelial carcinoma is present.
• People whose cancer has spread to other parts of the body (metastatic) or cannot be removed by surgery.
• People who have previously been treated with a type of immunotherapy called a checkpoint inhibitor (a PD-1 or PD-L1 inhibitor), either alone or in combination with another treatment.
• People who have previously received platinum-based chemotherapy, or whose doctor has determined they are not suitable for it at the time of joining the trial.
• People whose side effects from past treatments have either returned to their normal baseline or are mild (grade 1 or lower), unless the side effects are minor and well-managed.
• People who have a tumour tissue sample available to submit before starting the trial, or who are willing to have a new biopsy taken.
• People whose cancer can be measured on scans, according to a standard medical measurement system called RECIST 1.1.
• People with a general health and activity level score of 0, 1, or 2 on a standard scale used in cancer trials (ECOG performance status), meaning they are able to carry out at least some daily activities (confirm with trial site).
• People aged 18 years or older.
• People with blood test results within acceptable ranges in the 28 days before the first dose, including: sufficient levels of white blood cells, neutrophils, platelets, and haemoglobin — without needing recent transfusions or certain medications to boost these levels.
• People with liver function blood test results within acceptable ranges in the 28 days before the first dose.
• People with blood clotting test results within acceptable ranges, or who are on a stable, permitted blood-thinning medication, in the 28 days before the first dose.
• People with kidneys functioning well enough, based on a calculated measure of kidney function of at least 30 mL/min, in the 28 days before the first dose.
• People with urine protein levels within acceptable ranges in the 28 days before the first dose.
• People who are able to understand the trial requirements and have signed a consent form agreeing to take part.
• People who are sexually active and able to have children must agree to use accepted contraception methods during the trial and for 4 months after the last dose.
• Women of childbearing potential must not be pregnant at the time of screening, and must have a negative pregnancy test confirmed before starting the trial.

Who may not be able to join:

• People who have previously been treated with the drug cabozantinib.
• People who have previously taken part in an enfortumab vedotin study, or who have received a similar type of drug (MMAE-based antibody-drug conjugate).
• People who have taken a small molecule kinase inhibitor (a specific type of targeted cancer medicine) within 2 weeks before the first dose.
• People who have received any other systemic cancer treatment (including chemotherapy, biological therapy, or experimental treatments) within 2 weeks before the first dose.
• People who have had radiation therapy within 2 weeks before the first dose, or treatment with radioactive substances within 6 weeks before the first dose.
• People with cancer that has spread to the brain or the area around the brain, unless it has been successfully treated and has been stable for at least 4 weeks, the person has no neurological symptoms, and they are not taking steroid medications.
• People currently taking certain blood-thinning medications, including warfarin, dabigatran, betrixaban, or clopidogrel. Some other blood thinners may be permitted under specific conditions (confirm with trial site).
• People with serious uncontrolled heart conditions, including severe heart failure, unstable chest pain, dangerous heart rhythm problems, blood pressure that remains too high despite treatment, or a stroke, heart attack, blood clot, or similar event within the past 6 months.
• People with serious stomach or bowel problems, including tumour growing into the digestive tract, active stomach ulcers, inflammatory bowel disease, or certain other digestive conditions. People who have had a bowel perforation, bowel obstruction, or abdominal abscess within the past 6 months are also not eligible.
• People who have had significant bleeding — such as blood in urine, vomiting blood, or coughing up blood — within the past 12 weeks.
• People with certain lung conditions, including cavity-forming lesions in the lungs or cancer affecting the airways.
• People with tumours growing into or wrapped around major blood vessels.
• People with moderate or severe nerve damage (neuropathy grade 2 or higher) affecting sensation or movement.
• People with other significant health conditions, including serious unhealed wounds, uncontrolled thyroid problems, moderate to severe liver disease, or poorly controlled diabetes (confirmed by a blood sugar marker of 8% or higher).
• People who have had major surgery within 2 weeks, or minor surgery within 10 days, before the first dose, or who have not fully healed from a previous surgery.
• People with a specific heart electrical reading (QTcF interval) above 500 ms on a heart tracing (ECG) taken within 14 days before the first dose.
• People who are pregnant or breastfeeding.
• People who are unable to swallow tablets.
• People with a known allergy or sensitivity to any of the ingredients in the study treatments.
• People who have another active cancer at the time of joining, or who have been diagnosed with another cancer within the past 3 years that requires active treatment. Some exceptions may apply for certain minor skin cancers or other cancers considered to be fully treated (confirm with trial site).

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