Study on Sacituzumab Tirumotecan (Sac-TMT) for Treating Advanced Urothelial Cancer

Inclusion Criteria

• Have advanced urothelial cancer that cannot be removed by surgery or treated with radiation to cure it.
• Have cancer that can be measured by scans.
• Have previously received treatments including anti-PD-L1 therapy, platinum-based chemotherapy, and enfortumab vedotin (EV).
• May have received disitamab vedotin (DV) instead of EV in China.
• Have had no more than three previous lines of therapy.
• Have cancer that has worsened on scans after the last treatment.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Be eligible to receive one of the non-platinum chemotherapy options (paclitaxel, docetaxel, or vinflunine).
• Be able to provide a tumor sample for testing.
• If HIV positive, have well-controlled HIV with treatment.
• If hepatitis B positive, have undetectable viral load after treatment.
• If previously infected with hepatitis C, have undetectable viral load.
• Have adequate organ function.

Exclusion Criteria

• Have severe eye conditions that affect healing.
• Have uncontrolled heart or blood vessel diseases.
• Have a history of lung diseases that required steroids.
• Have HIV with a history of certain cancers.
• Have not recovered from side effects of previous cancer treatments.
• Have received a TROP2-targeted therapy or a topoisomerase 1 inhibitor.
• Have had recent radiation therapy or related side effects.
• Have received a live vaccine recently.
• Have had previous chemotherapy with the study drugs.
• Have used an investigational drug or device recently.
• Have an immune deficiency or are on immunosuppressive therapy.
• Have another active cancer needing treatment in the past 3 years.
• Have cancer that has spread to the brain or spinal cord.
• Have an active infection needing treatment.
• Have had a stem cell or organ transplant.
• Have not recovered from major surgery.