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Prostate CancerOpen to EnrollmentPhase 3

BLADDER: METASTATIC: 2nd LINE: TROPION-Urothelial03

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)

Study snapshot

Title
Daiichi Sankyo DS1062-328 Urothelial DatoDxD
Malignancy
Bladder cancer, urothelial cancer
Stage
Stage 4
Disease setting
Locally advanced/Metastatic
Line of therapy
2nd Line
Investigational agent
Datopotamab Deruxtecan
Drug class
TROP-2 ADC
Principal investigator
Brad Somer, MD
Sponsor
Daiichi Sankyo
Path
Transitional cell urothelial carcinoma
Randomized
Yes
ClinicalTrials.gov ID
NCT07129993

Eligibility and objectives

Key eligibility criteria details

  • Unresectable locally advanced or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra
  • No urachal, small cell, or adenocarcinoma are allowed
  • Squamous differentiation or mixed cell types are eligible if histology is predominantly transitional cell
  • Must have had progression of disease after the combination of enfortamab vedotin and pembrolizumab. Can have stopped EV+pembro due to toxicity as long as has had disease progression since then.
  • No metastatic prostate cancer, but early stage prostate cancer is allowed if there is no rising PSA and is not currently getting ADT
  • Must have tumor tissue sample (can be archival)
  • Must be eligible to receive platinum containing chemotherapy
  • If patient received gemcitabine, carboplatin, or cisplatin for early UC, at least 1 year must have passed since the last dose
  • No prior TROP2 directed ADC therapy
  • No uncontrolled or significant cardiac disease
  • No history of pneumonitis or clinically severe pulmonary disease

Objective

  • Primary
    • PFS
    • OS
  • Secondary
    • DoR
    • Investigator PFS
    • ORR

Treatment details