drugset / Trial / NCT07129993
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
RandomizedSequentialOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2025-09-26
- Primary completion
- 2029-06-01
- Completion
- 2030-01-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Datopotamab deruxtecan | Monoclonal antibody | 4 mg/kg | Intravenous |
| Subject | Datopotamab deruxtecan | Monoclonal antibody | 6 mg/kg | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Carboplatin | Small molecule | 4.5 unknown | Intravenous |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Cisplatin | Other / unclassified | 70 mg/m2 | Intravenous |