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Study identifier: NCT07129993 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Urothelial Cancer · Bladder Cancer  ·  Sponsor: Daiichi Sankyo

PhasePhase 2/Phase 3
Planned participants630
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Contact for Trial Information  ·  908-992-6400  ·  CTRinfo_us@daiichisankyo.com

Always discuss trial participation with your own doctor first.

Locations (100)

Research SiteFullerton, California, United StatesActive Not Recruiting
Research SiteGlendale, California, United StatesActive Not Recruiting
Research SiteLa Jolla, California, United StatesActive Not Recruiting
Research SiteLos Angeles, California, United StatesRecruiting
Research SiteOrange, California, United StatesActive Not Recruiting
Research SiteSan Francisco, California, United StatesActive Not Recruiting
Research SiteAurora, Colorado, United StatesActive Not Recruiting
Research SiteOrange City, Florida, United StatesActive Not Recruiting
Research SiteSt. Petersburg, Florida, United StatesActive Not Recruiting
Research SiteTamarac, Florida, United StatesActive Not Recruiting
Research SiteAtlanta, Georgia, United StatesActive Not Recruiting
Research SiteLocust Grove, Georgia, United StatesActive Not Recruiting

+ 88 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07129993