What is Datopotamab Deruxtecan (Dato-DXd) studying for urothelial carcinoma?

Datopotamab Deruxtecan (Dato-DXd) is being studied to see how it works in combination with carboplatin or cisplatin compared to the current standard treatment with gemcitabine and platinum drugs in people with advanced urothelial carcinoma. The trial focuses on patients whose cancer has progressed after prior treatment with enfortumab vedotin plus pembrolizumab. This research is sponsored by Daiichi Sankyo and aims to find better treatment options.

Who may be eligible for this urothelial carcinoma clinical trial?

Adults aged 18 years or older with locally advanced or metastatic urothelial carcinoma who have experienced progression after treatment with enfortumab vedotin plus pembrolizumab may be eligible. Both men and women can participate. Important factors include kidney function, heart health, and no severe lung disease. Please review eligibility criteria for more details.

Is there any cost to participate in this urothelial carcinoma clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other incidental costs may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years +

All Genders

ID07129993

A Randomized, Open-Label, Phase 23 Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma Who Progressed After Enfortumab Vedotin Plus Pembrolizumab

Led by Daiichi Sankyo · Updated on 2026-06-08

630

Participants Needed

Research Sites

33 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying treatments for people with locally advanced or metastatic urothelial carcinoma who have not responded to previous combination therapy with enfortumab vedotin plus pembrolizumab. This global, multicenter trial is a Phase 23 randomized, open-label study comparing a new drug called Datopotamab Deruxtecan Dato-DXd combined with carboplatin or cisplatin against the standard treatment of gemcitabine combined with carboplatin or cisplatin. The trial aims to assess preliminary effectiveness and safety in Phase 2 before determining the best dose for Phase 3 evaluation. Participants will receive Dato-DXd given as an intravenous infusion every three weeks at doses of 4 mgkg, 6 mgkg, or the recommended Phase 3 dose RP3D alongside carboplatin or cisplatin. Carboplatin and cisplatin are also given by intravenous infusion every three weeks, with specific dosing levels. Gemcitabine is administered intravenously on Days 1 and 8 of a 21-day cycle. The study starts with Part A Phase 2 to evaluate activity and safety, followed by Part B Phase 3 to further compare treatments using the dose determined in Part A. During the study, participants will have regular assessments including scans to track tumor response and progression, survival status, and safety monitoring. Researchers will measure overall response rate, progression-free survival, and overall survival over periods up to about 34 to 38 months depending on the phase. The study will also collect tissue samples for biomarker testing. Participants will be closely monitored for side effects and treatment tolerability throughout the trial period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adult aged 18 years or older at the time of consent
Histologically or cytologically confirmed unresectable locally advanced or metastatic urothelial carcinoma of bladder, renal pelvis, ureter, or urethra
Urothelial carcinoma with squamous differentiation or mixed cell types allowed if predominantly urothelial
No urachal, small cell, or adenocarcinoma histology
History of nonclinically active prostate cancer allowed if no radiological metastasis and no rising PSA or androgen deprivation therapy
Prior progression during or after enfortumab vedotin plus pembrolizumab treatment
Eligible to receive cisplatin or carboplatin chemotherapy per investigator judgment
Specific renal function criteria for cisplatin eligibility (e.g., GFR thresholds and clinical judgment)
Stable chronic Grade 2 toxicities from previous anticancer therapy permitted if managed and not worsening
Must provide tumor tissue sample for biomarker testing

You will not qualify if you...

Prior systemic therapy for locally advanced or metastatic urothelial carcinoma other than enfortumab vedotin plus pembrolizumab
History of allogeneic bone marrow or solid organ transplant
Use of prohibited medications during the trial
Prior TROP2 directed antibody-drug conjugate therapy
Uncontrolled or significant cardiovascular disease (e.g., QTcF >470 ms, recent myocardial infarction, uncontrolled angina, NYHA Class 3 or 4 heart failure, uncontrolled hypertension)
History or current interstitial lung disease or pneumonitis requiring steroids
Clinically severe pulmonary compromise or autoimmune pulmonary disorders
Unresolved toxicities from prior anticancer therapy above Grade 1, except stable chronic Grade 2 toxicities as defined

Research Team

Contact for Trial Information

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