Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
Recruiting now · Phase 2/Phase 3
Conditions studied: Urothelial Cancer, Bladder Cancer
In brief
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.
Key facts
- Study ID
- NCT07129993
- Run by
- Daiichi Sankyo
- People needed
- 630
- Starts
- 2025-09-26
- Expected to finish
- 2030-01-22
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — Montpellier, France (enrolling)
- Research Site — Kōtoku, Japan (enrolling)
- Research Site — Bordeaux, France (enrolling)
- Research Site — Lyon, France (enrolling)
- Research Site — Nürtingen, Germany (enrolling)
- Research Site — Kawasaki, Japan (enrolling)
- Research Site — Dallas, Texas, United States (enrolling)
- Research Site — Beijing, China (enrolling)
- Research Site — Créteil, France (enrolling)
- Research Site — Le Mans, France (enrolling)
- Research Site — Saint-Etienne, France (enrolling)
- Research Site — Vandœuvre-lès-Nancy, France (enrolling)
- Research Site — Niles, Illinois, United States (enrolling)
- Research Site — Peoria, Illinois, United States (enrolling)
- Research Site — Los Angeles, California, United States (enrolling)
- Research Site — Nashville, Tennessee, United States (enrolling)
- Research Site — Grand Rapids, Michigan, United States (enrolling)
- Research Site — Norfolk, Virginia, United States (enrolling)
- Research Site — Brest, France (enrolling)
- Research Site — Cedex 10, France (enrolling)
- Research Site — Chapel Hill, North Carolina, United States (enrolling)
- Research Site — La Roche-sur-Yon, France (enrolling)
- Research Site — Paris, France (enrolling)
- Research Site — Poitiers, France (enrolling)
- Research Site — Nagoya, Japan (enrolling)
Full record on ClinicalTrials.gov
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