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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

630

Participants

Timeline

Start Date

September 26, 2025

Primary Completion Date

June 1, 2029

Study Completion Date

January 22, 2030

Conditions
Urothelial CancerBladder Cancer
Interventions
DRUG

Dato-DXd

Dato-DXd will be administered as an intravenous (IV) infusion every three weeks (Q3W) at a dose of 4 mg/kg or 6 mg/kg in Part A or RP3D in Part B

DRUG

Carboplatin

Carboplatin will be administered as an intravenous (IV) infusion every three weeks (Q3W) at a dose of AUC 4.5 or 5.0 mg•min/mL

DRUG

Cisplatin

Cisplatin will be administered as an intravenous (IV) infusion every three weeks (Q3W) at a dose of 70 mg/m2

DRUG

Gemcitabine

Gemcitabine will be administered as an IV infusion at a dose of 1000 mg/m2 on Day 1 and 8 of every 3 week cycle.

Trial Locations (5)

32763

ACTIVE_NOT_RECRUITING

Research Site, Orange City

33322

ACTIVE_NOT_RECRUITING

Research Site, Austin

37203

RECRUITING

Research Site, Nashville

62269

ACTIVE_NOT_RECRUITING

Research Site, Tamarac

62401

ACTIVE_NOT_RECRUITING

Research Site, Effingham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Daiichi Sankyo

INDUSTRY