At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 24 target
Drug / intervention
Disitamab Vedotin for injectiondrug
Likely dose
Not stated in record
Key inclusion· 9
- ✓Age 18-75 years
- ✓Histologically confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC)
- ✓High-risk or very high-risk group status
- ✓High-grade/G3 tumor with CIS, T1 stage, diameter >3cm, or multiple/recurrent tumors
Key exclusion· 6
- ✕Invasive bladder cancer T2 stage or above
- ✕Regional lymph node or distant metastasis
- ✕Combined urothelial carcinoma outside bladder (urethra, ureter, renal pelvis)
- ✕Any prior antitumor therapy within 4 weeks before study administration
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Single-arm, Multicenter Phase I/II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2
In Brief
A Phase 2 clinical trial evaluating Disitamab Vedotin for injection for High-risk Non-muscle Invasive Bladder Cancer. Currently recruiting, targeting 24 participants across 6 sites.
Detailed Summary
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--
Timeline
Phase 2Recruiting
202520262027202820292030
First PostedApr 2024
Enrollment StartJun 2024
TodayJul 2026
Primary CompletionMar 2029
Study CompletionDec 2029
First PostedApr 22, 2024
Enrollment StartJun 14, 2024
Primary CompletionMar 15, 2029
Study CompletionDec 31, 2029
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 2.2 years agoPrimary completion in 2.7 years
Interventions
Disitamab Vedotin for injectiondrug
Intravesical instiliations into the bladder