Study on Sapanisertib for Treating Advanced or Metastatic Bladder Cancer with TSC1 and/or TSC2 Mutations

Inclusion Criteria

• Must have bladder cancer that can be measured and has spread locally or to other parts of the body.
• Must have a specific type of bladder cancer called transitional cell carcinoma (TCC) with TSC1 or TSC2 mutations.
• Must have cancer that has progressed after treatment with at least one platinum-based chemotherapy regimen or be unable to receive such treatment.
• Must be in relatively good health with a performance status score of 2 or less.
• Must have a life expectancy of more than 12 weeks.
• Must meet specific blood and organ function criteria, including adequate blood cell counts and normal liver and kidney function.
• Women of childbearing potential must agree to use effective contraception during the study and for 90 days after the last dose.
• Men must agree to use effective contraception during the study and for 120 days after the last dose.
• Must be able to swallow pills and understand the study requirements.

Exclusion Criteria

• Cannot have received chemotherapy, immunotherapy, or investigational therapy within four weeks before starting the study drug.
• Cannot have untreated or symptomatic brain or spinal cord metastases.
• Cannot have a history of severe allergic reactions to similar drugs.
• Cannot be taking certain medications that affect the liver enzymes needed to process the study drug.
• Cannot have uncontrolled illnesses, such as severe heart or lung disease.
• Cannot be pregnant or breastfeeding.
• Cannot have active infections like hepatitis B, hepatitis C, or HIV that are not well controlled.
• Cannot have had recent heart or blood vessel problems, such as a heart attack or stroke.
• Cannot have received certain cancer treatments, like PI3K, AKT, or mTOR inhibitors, before.