RecruitingPhase 1Phase 2NCT06732531

Safety, Tolerability, and Preliminary Efficacy of BH011 in Subjects With Non-Muscle-Invasive Bladder Cancer

A Phase I/II, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of BH011 in Subjects With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer After Bacillus Calmette-Guérin

Sponsor

Zhuhai Beihai Biotech Co., Ltd

Enrollment

48 participants

Start Date

Aug 3, 2022

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer Non Muscle Invasive

Summary

The purpose of this study is to determine the safety and tolerability of intravesical BH011 in patients with high-risk non-muscle invasive bladder cancer（NMIBC） after Bacillus Calmette-Guerin（BCG） failure and to assess the preliminary efficacy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BH011 given directly into the bladder in people with high-risk, non-muscle-invasive bladder cancer (NMIBC) who have already tried and failed standard BCG therapy (a common bladder cancer treatment) and are not candidates for or do not want bladder removal surgery. **You may be eligible if...** - You are 18 or older - You have confirmed high-risk non-muscle-invasive bladder cancer - You completed a bladder tumor removal procedure (TURBT) within the past 12 weeks - BCG therapy did not work for you (your cancer was BCG-refractory, recurred, was non-responsive, or you could not tolerate BCG) - You are not a candidate for or have declined radical cystectomy (bladder removal surgery) **You may NOT be eligible if...** - Your cancer has grown into the bladder muscle or spread beyond the bladder - You have serious other health conditions preventing participation - 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.

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Interventions

DRUGBH011

BH011 is administered intravesically through a urinary catheter and is retained in the bladder for 1 hour. It was administered once a week for 6 weeks during the induction treatment period and once a month for 12 months during the maintenance treatment period.