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NCT07129993 · ClinicalTrials.gov registry record · Phase 2
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
A Phase 2 study of Bladder Cancer and Urothelial Cancer, sponsored by Daiichi Sankyo.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 630
- Enrollment target
- 20
- Study locations
NCT07129993 is a Phase 2 study of Bladder Cancer and Urothelial Cancer that is actively recruiting participants, run by Daiichi Sankyo. The registered enrollment target is 630 participants, below the 12,750-participant average among 175 other Bladder Cancer trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT07129993, a Phase 2 study of Bladder Cancer and Urothelial Cancer, is actively recruiting participants, sponsored by Daiichi Sankyo.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 630 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Dato-DXd
Study Locations (20)
California
- Research Site - Fullerton
- Research Site - La Jolla
- Research Site - San Francisco
Florida
- Research Site - Orange City
- Research Site - St. Petersburg
- Research Site - Tamarac
Illinois
- Research Site - Effingham
- Research Site - Niles
- Research Site - Peoria
Georgia
- Research Site - Atlanta
- Research Site - Locust Grove
Colorado
- Research Site - Aurora
Maryland
- Research Site - Largo
Michigan
- Research Site - Grand Rapids
Missouri
- Research Site - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 630 participants |
| Start Date | 2025-09-26 |
| Est. Completion | 2030-01-22 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07129993
The ClinicalTrials.gov registry entry for NCT07129993 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 630 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,750-participant average among 175 other Bladder Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT07129993 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT07129993 about?
NCT07129993 is a clinical study titled "Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma". 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...
What is the current status of trial NCT07129993?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 630 participants. The study started on 2025-09-26. Estimated completion is 2030-01-22.
What conditions does trial NCT07129993 study?
This clinical trial studies the following conditions: Bladder Cancer, Urothelial Cancer.
What interventions are being tested in trial NCT07129993?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), Dato-DXd (DRUG).
Who is sponsoring clinical trial NCT07129993?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07129993 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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