NCT06187506

Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer

A Prospective, Open, Single-center Clinical Study of Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will include patients with very high risk NMIBC with HER2 expression (IHC 1+/2+/3+) who refuse to undergo cystectomy or do not meet the requirements for cystectomy. Reasons for unsuitability or refusal of cystectomy will be documented on an electronic case report form (eCRF). Subjects will receive 6 months of Disitamab Vedotin therapy and at least 1 year of BCG therapy. EFS(Event free survival) and CR(Complete response) rates will be evaluated after treatment by cystoscopy, pathologic histology, urine cytology, laboratory tests, and imaging. Cystoscopy and urine cytology every three months for two years, and radiography every six months. Cystoscopy and urine cytology were done every six months and radiography once a year after two years.

Conditions

• Non-muscle Invasive Bladder Cancer
• HER-2 Protein Overexpression

Interventions

Type	Name	Description
DRUG	Disitamab vedotin	2.0 mg/kg, administered intravenously every three weeks
DRUG	Bacillus Calmette Guerin Vaccine	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.

Timeline

• Start date: 2023-12-18
• Primary completion: 2026-04-01
• Completion: 2027-01-01
• First posted: 2024-01-02
• Last updated: 2024-07-12

Locations

1 site across 1 country: China