At a glance
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NCT06187506Phase 2RecruitingMonitorUpdated 23mo ago · Completion was 3mo agoA Prospective, Open, Single-center Clinical Study of Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer
In Brief
A Phase 2 clinical trial evaluating Disitamab vedotin and Bacillus Calmette Guerin Vaccine for Non-muscle Invasive Bladder Cancer and HER-2 Protein Overexpression. Currently recruiting, targeting 20 participants across 1 site.
Signals
Detailed Summary
This is a prospective, open, single-center clinical study of the anti-HER2(Human epidermal growth factor receptor-2) ADC(antibody-drug conjugate) drug Disitamab Vedotin in combination with BCG(bacillus Calmette-Guerin) therapy in very high-risk NMIBC(Non-muscle invasive bladder cancer) patients with HER2 expression (IHC 1+/2+/3+), which is being conducted in accordance with the Good Clinical Practice for Pharmaceutical Trials (GCP). Approximately 20 subjects will be enrolled in this study to evaluate the efficacy and safety of Disitamab Vedotin (2.0 mg/kg, administered intravenously every three weeks) in combination with BCG therapy.
Study Details
Timeline
Interventions
2.0 mg/kg, administered intravenously every three weeks
Induction therapy, i.e., intravesical therapy once a week for 6 weeks. maintenance therapy, i.e., one course of maintenance therapy at three, six and twelve months after surgery, each course once a week for 3 weeks.