Study on Sacituzumab Tirumotecan for Patients with Bladder Cancer

Inclusion Criteria

• Have recurrent low-grade Non-Muscle Invasive Bladder Cancer (NMIBC).
• Must have a visible tumor seen through a cystoscopy within 12 weeks before the first dose.
• Have intermediate-risk NMIBC, which includes one or more of the following:
  • Multiple tumors.
  • More than one occurrence of low-grade NMIBC within one year of the current diagnosis.
  • Early recurrence of low-grade disease within one year of the initial diagnosis.
  • A single tumor larger than 3 cm.
  • Previous intravesical treatment that did not work.
• Have an ECOG performance status score between 0 and 2, assessed within 14 days before the first dose.

Exclusion Criteria

• Have newly diagnosed low-grade nonmuscle invasive bladder cancer.
• Have a past or current history of high-grade NMIBC, muscle invasive bladder cancer, or metastatic urothelial carcinoma.
• Have a condition that prevents normal bladder emptying or holding urine for 1 to 2 hours.
• Have a history of severe dry eye syndrome, severe Meibomian gland disease, blepharitis, or corneal disease that affects corneal healing.
• Have active inflammatory bowel disease requiring immunosuppressive medication or a history of inflammatory bowel disease like Crohn's disease, ulcerative colitis, or chronic diarrhea.
• Have uncontrolled significant heart or blood vessel disease.
• Have another cancer that is progressing or required treatment in the past 3 years.
• Have a history of lung inflammation or interstitial lung disease that required steroids, or currently have these lung conditions.