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

About the trial

Sponsor

Daiichi Sankyo (with AstraZeneca)

Tested

Dato-DXd (drug), Carboplatin (drug), Cisplatin (drug), Gemcitabine (drug)

Dates

Started 2025-09-26; completion 2030-01-22

Results posted

Not yet

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.

From ClinicalTrials.gov, last updated 2026-08-20. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Daiichi Sankyo Inc. reported $285,427 in research payments for this study in 2025 (134 payments).

Products named: Datroway

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.