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

NCT06732531 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-01-09

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Zhuhai Beihai Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Xiaohua Wei · Zhuhai Beihai Biotech Co., Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-03
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06732531 on ClinicalTrials.gov