Study Comparing T-bren with Standard Chemotherapy for HER2-positive Metastatic Urothelial Cancer After Anti-PD-(L)1 Therapy

Inclusion Criteria

• Have a confirmed diagnosis of metastatic or inoperable transitional cell carcinoma (TCC) of the urinary system, including the renal pelvis, ureter, bladder, or urethra.
• The cancer must have worsened during or after treatment with anti-PD-(L)1 therapy.
• Provide a fresh or archived tumor sample for testing.
• Have HER2-positive cancer as confirmed by a central lab.
• Be eligible to receive chemotherapy with carboplatin or cisplatin and gemcitabine.
• Have at least one tumor that can be measured by scans.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have adequate organ function and blood clotting ability.

Exclusion Criteria

• Have received prior treatment with topoisomerase inhibitor-based ADC therapy.
• Have primary tumors in the brain, active or untreated brain metastases, or cancer in the membranes covering the brain and spinal cord.
• Have bladder cancer with small cell histology.
• Have other cancers, except for certain localized cancers or low-grade prostate cancer, or other cancers treated with curative intent and a disease-free period of at least 3 years.
• Have a history of significant bleeding or gastrointestinal perforation within 6 months before joining the study.
• Have active autoimmune or inflammatory diseases.
• Have a history of lung disease requiring steroid treatment, current lung disease, or suspected lung disease that cannot be ruled out by imaging.
• Have advanced lung disease, such as poorly controlled COPD or asthma, within 6 months before joining the study.
• Have HIV infection.
• Have active hepatitis B or C infection.
• Have active or latent tuberculosis.
• Other specific criteria as outlined in the study protocol.