Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING 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

NCT07129993 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 630 participants
Start Date 2025-09-26
Est. Completion 2030-01-22
Phase Phase 2

Sponsor

Daiichi Sankyo

157 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 630 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 157 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07129993 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07129993?

The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), Dato-DXd (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07129993?

This trial is sponsored by Daiichi Sankyo, which has 157 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial