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

ClinicalTrials.gov ID: NCT07129993

Public ClinicalTrials.gov record NCT07129993. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 8, 2026, 4:30 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Open-Label, Phase 2/3 Study of Datopotamab Deruxtecan (Dato-DXd) Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) Who Progressed During or After Enfortumab Vedotin (EV) Plus Pembrolizumab Combination Treatment TROPION-Urothelial03 (TU03)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07129993
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Daiichi Sankyo; Industry
Enrollment: 630 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 25, 2025
Primary completion: May 31, 2029
Completion: Jan 21, 2030
Last update posted: Aug 19, 2026

2025 – 2030

United States locations

U.S. sites: 38
U.S. states: 21
U.S. cities: 37

Facility	City	State	ZIP	Site status
Research Site	Fullerton	California	92835	Active, not recruiting
Research Site	Glendale	California	91204	Active, not recruiting
Research Site	La Jolla	California	92093	Active, not recruiting
Research Site	Los Angeles	California	90024	Recruiting
Research Site	Orange	California	92868	Active, not recruiting
Research Site	San Francisco	California	94158	Active, not recruiting
Research Site	Aurora	Colorado	80012	Active, not recruiting
Research Site	Orange City	Florida	32763	Active, not recruiting
Research Site	St. Petersburg	Florida	33701	Active, not recruiting
Research Site	Tamarac	Florida	62269	Active, not recruiting
Research Site	Atlanta	Georgia	30342	Active, not recruiting
Research Site	Locust Grove	Georgia	30248	Active, not recruiting
Research Site	Effingham	Illinois	62401	Active, not recruiting
Research Site	Niles	Illinois	60714	Recruiting
Research Site	Peoria	Illinois	61615	Recruiting
Research Site	Largo	Maryland	20774	Active, not recruiting
Research Site	Boston	Massachusetts	02216	Active, not recruiting
Research Site	Grand Rapids	Michigan	49546	Recruiting
Research Site	Rochester	Minnesota	55905	Active, not recruiting
Research Site	St Louis	Missouri	63110	Active, not recruiting
Research Site	New York	New York	10029	Active, not recruiting
Research Site	Chapel Hill	North Carolina	27514	Recruiting
Research Site	Raleigh	North Carolina	27610	Active, not recruiting
Research Site	Portland	Oregon	97227	Active, not recruiting
Research Site	Monroeville	Pennsylvania	15146	Active, not recruiting
Research Site	Philadelphia	Pennsylvania	19107	Active, not recruiting
Research Site	Providence	Rhode Island	02906	Active, not recruiting
Research Site	Myrtle Beach	South Carolina	29572	Active, not recruiting
Research Site	Germantown	Tennessee	38138	Active, not recruiting
Research Site	Memphis	Tennessee	38120	Active, not recruiting
Research Site	Nashville	Tennessee	37203	Recruiting
Research Site	Austin	Texas	33322	Active, not recruiting
Research Site	Dallas	Texas	75246	Recruiting
Research Site	Dallas	Texas	75390	Active, not recruiting
Research Site	Charlottesville	Virginia	22908	Active, not recruiting
Research Site	Norfolk	Virginia	23502-1871	Recruiting
Research Site	Spokane	Washington	99208	Active, not recruiting
Research Site	Madison	Wisconsin	53715	Active, not recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 61 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07129993, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 19, 2026 · Synced Sep 8, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07129993 live on ClinicalTrials.gov.

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