NCT06732531

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Zhuhai Beihai Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The plan is to study the safety and preliminary efficacy of BH011 in High-Risk NMIBC patients who failed BCG therapy. Most patients with NMIBC is (Cis, Cis with Ta and/or T1, high grade Ta or T1 with frequent or uncontrolled recurrences) who have failed BCG intravesical therapy (standard of care) usually have no other choice but to proceed to cystectomy. Cystectomy is a surgery associated with major morbidity, mortality and quality of life issues. Morbidity and long term tedious medical care will be for the rest of the patient's life span. Most patients at this stage do not show signs of disease progression into the muscle layer or of metastasis, making surgery a very difficult decision. BH011 will serve to provide a therapeutic alternative for this patient population in need. In this study, patients will begin treatment with BH011 2-8 weeks after TURBT and will be administered once weekly for 6 weeks during the induction treatment period and once monthly for 12 months in the maintenance treatment period. Patients will undergo cystoscopy, urine cytology, and biopsy every 3 months for up to 24 months to confirm clinical efficacy.

Conditions

• Bladder Cancer
• Non Muscle Invasive

Interventions

Type	Name	Description
DRUG	BH011	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.

Timeline

• Start date: 2022-08-03
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-12-13
• Last updated: 2025-01-09

Locations

6 sites across 1 country: China