A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

Inclusion Criteria: Cohorts A and B * Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra * Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy * At least one measurable lesion by investigator assessment based on RECIST version 1.1. * HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Cohort C * Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra * No prior systemic therapy for LA/mUC * Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy * At least one measurable lesion by investigator assessment based on RECIST v1.1. * Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation * HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, on the provided tumor tissue sample * ECOG performance status of 0, 1, or 2 Cohort D * Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra * Based on…