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DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC

Study acronym: HERO
StatusRecruiting
PhasePhase 3
Started2025-12-01
View on ClinicalTrials.gov ↗

Amendment history

2026-07-17
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
Collaborators-172 characters
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Fujian Cancer Hospital Tenth People's Hospital of Tongji Univeristy Ningbo Medical Center Lihuili Hospital
2025-09-28
Original filing
Fudan University
624 trials monitored
See 9 trials at risk
Bladder Cancer
1,018 trials monitored
See 64 trials at risk
The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk. Each participant was assigned to one of two study treatment groups: One group is given Disitamab Vedotin and BCG.The second group is given BCG only and will not receive Disitamab Vedotin.
Trial Details
NCT Number NCT07207824
Lead Sponsor Fudan University
Conditions Bladder (Urothelial, Transitional Cell) Cancer, NMIBC
Enrollment 182 participants
Start Date 2025-12-01
Primary Completion 2030-06-01 (estimated)
Study Completion 2030-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-21