Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma

This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la/mUC who progressed during or after EV plus pembrolizumab combination treatment. This trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacy and safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identified when the data allow sufficient assessment of activity, safety, and tolerability. The Phase 3 part will start contingent upon the assessment in the Phase 2 part, taking into consideration the totality of information.

NCT Number	NCT07129993
Lead Sponsor	Daiichi Sankyo Collaborators: AstraZeneca
Conditions	Urothelial Cancer, Bladder Cancer
Enrollment	630 participants
Start Date	2025-09-26
Primary Completion	2029-06-01 (estimated)
Study Completion	2030-01-22 (estimated)
Updated on ClinicalTrials.gov	2026-07-27