Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
← catalyst calendarNCT07129993 · readout in 1,017 d
Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With AstraZeneca.
Phase
Phase 2/3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
630estimated
Sites
100
Countries
Austria, China, France +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-09-26 | actual | When the study began enrolling |
| Primary completion | 2029-06-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-01-22 | estimated | The whole study's end, after follow-up |
| First posted | 2025-08-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Urothelial Cancer
- Bladder Cancer
Interventions
- Drug: Dato-DXd — also filed as Datopotamab Deruxtecan
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Gemcitabine
Primary outcomes
what the primary-completion date above is the date OFOverall Response Rate - Part A (Phase 2)
measured From Phase 2 randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, up to approximately 34 months
Progression Free Survival as Assessed by Blinded Independent Central Review (BICR) - Part B (Phase 3)
measured From Phase 3 randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, up to approximately 38 months
Overall Survival - Part B (Phase 3)
measured From Phase 3 randomization to death due to any cause, up to approximately 38 months
Publications
- PMID 42142358 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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