RecruitingPhase 2NCT06187506

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

Sponsor

Fudan University

Enrollment

20 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

HER-2 Protein Overexpression Non Muscle Invasive Bladder Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a targeted antibody-drug combination (disitamab vedotin) given together with BCG bladder instillation therapy in people with high-risk, non-muscle-invasive bladder cancer whose tumors express the HER2 protein. **You may be eligible if...** - You are 18 or older - You have non-muscle-invasive bladder cancer confirmed by biopsy (cancer confined to the inner lining or just below it — Ta, Tis, or T1) - Your tumor is considered high-risk (e.g., high grade, lymphovascular invasion) - All visible tumors have been removed during a prior procedure (TURBT) - Your tumor cells express the HER2 protein **You may NOT be eligible if...** - Your cancer has grown into the bladder muscle or spread elsewhere - You have previously received certain targeted therapies or have contraindications to BCG - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDisitamab vedotin

2.0 mg/kg, administered intravenously every three weeks

DRUGBacillus 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.