Bladder Cancer

A Randomized Open-Label Phase 2/3 Study of Datopotamab-Deruxtecan (Dato-DXd) plus Carboplatin or Cisplatin versus Gemcitabine plus Carboplatin or Cisplatin in Participants with Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) who Progressed during or After Enfortumab Vedotin (EV) plus Pembrolizumab Combination Treatment - DS1062-328

MOA: Dato-DXD is an ADC that comprises a recombinant humanized anti-TROP2 IgG1 mAb that is covalently conjugated to a drug-linker, via thioether bonds.

Key Eligibility Criteria:

• Histologically or cytologically confirmed unresectable locally advanced or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra
• Subjects must be considered eligible to receive cisplatin- or carboplatin-containing therapy
• Must have experienced radiographic progression or relapse during or after 1L of EV/pembrolizumab
• Subjects that received prior therapy other than EV/pembrolizumab combo are excluded
• Subjects with history of allogenic transplant or prior TROP2 directed ADC therapy are excluded