RecruitingPhase 1NCT06551233

Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC)

A Clinical Study on the Safety and Efficacy of 9MW2821 in Patients With High-risk Non-muscle-invasive Bladder Cancer (NMIBC) That Have Previously Failed to Intravesical Therapy


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

30 participants

Start Date

Apr 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Assess the safety and efficacy of 9MW2821 in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who have previously failed to intravesical therapy. Provide a new treatment option for patients with NMIBC recurrence, reduce the risk of tumor recurrence, decrease the rate of radical bladder surgery, and enhance the quality of life for patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called 9MW2821 in people with high-risk bladder cancer that has not yet spread into the muscle wall (called non-muscle-invasive bladder cancer, or NMIBC). The drug is given directly into the bladder and is aimed at patients whose cancer has come back or who cannot tolerate the standard treatment (BCG therapy). **You may be eligible if...** - You are 18 or older with high-risk non-muscle-invasive bladder cancer (confirmed by biopsy) - You have already tried BCG or other bladder treatments and they did not work, or you cannot tolerate BCG - You had a TURBT surgery (to remove visible tumors) within the last 6 weeks with no residual tumor - You refuse or cannot undergo bladder removal surgery - Your cancer has not spread to lymph nodes or other parts of the body **You may NOT be eligible if...** - Your bladder cancer has invaded the muscle layer or spread elsewhere - You have had another cancer in the last 3 years - You have had an organ transplant, autoimmune disease, or active serious infection - You are positive for HIV or have active hepatitis B or C 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

DRUG9MW2821

Patients will be evaluated from low dose to high dose through intravesical therapy and then select the suitable doses to expand according to study data.


Locations(1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06551233


Related Trials