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 one of the following solid tumour cancers, depending on the group (cohort) they would be placed in: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer, head and neck squamous cell carcinoma, or prostate cancer
• People in Cohorts A1 or C who have already received all standard treatments considered appropriate by their treating doctor, or for whom no standard treatment is available (any number of prior treatments is acceptable)
• People in Cohorts A2, B1, or B2 who have received at least one prior treatment for advanced or metastatic disease (any number of prior treatments is acceptable)
• People in Cohort B1 whose cancer has not previously been treated with the drug enfortumab vedotin in the advanced or metastatic setting
• People in Cohort B2 who have previously received enfortumab vedotin for advanced or metastatic disease
• People in Cohorts A1/A2/C where prior treatment with enfortumab vedotin is permitted but not required
• People whose cancer can be measured or detected on scans according to standard criteria (Cohort A1 may also include people whose disease cannot be measured by standard criteria — confirm with trial site)
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
• People who have a stored tumour tissue sample available, or who are able to have a biopsy taken during screening (subject to local country regulations)

Who may not be able to join:

• People who have known or suspected brain or spinal cancer spread (CNS metastases) that is not well controlled
• People with uncontrolled high calcium levels in their blood
• People with uncontrolled diabetes
• People with evidence of certain eye conditions affecting the cornea, or who have had a corneal transplant
• People who still have serious unresolved side effects from previous cancer treatments
• People with significant heart or blood vessel disease
• People who have recently experienced a blood clot in a vein or artery, or who have a serious bleeding disorder
• People whose heart electrical activity shows a particular abnormality (a prolonged QTcF interval of 470 ms or more) on a heart tracing (ECG)
• People with a history of lung inflammation (pneumonitis) or scarring of the lungs (interstitial lung disease)
• People who previously had a severe (Grade 3 or higher) skin reaction while receiving enfortumab vedotin
• People who are pregnant, breastfeeding, or planning to breastfeed during the study or within 30 days of the last dose of the study treatment

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