Actively Recruiting
Safety, Tolerability, and Preliminary Efficacy of BH011 in Subjects With Non-Muscle-Invasive Bladder Cancer
Led by Zhuhai Beihai Biotech Co., Ltd · Updated on 2025-01-09
48
Participants Needed
6
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety, Tolerability, and Preliminary Efficacy of BH011 in Subjects With Non-Muscle-Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Willing and able to provide informed consent and complete the study
- Histologically confirmed high-risk non-muscle invasive bladder cancer diagnosed within 12 weeks prior to first dose
- Failed prior intravesical BCG treatment and are not candidates for or refuse radical cystectomy
- Complete tumor removal confirmed after TURBT; second TURBT performed if indicated
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 6 months
- Adequate bone marrow, liver, and kidney function as specified (HGB ≥80 g/L, PLT ≥100 x10^9/L, ANC ≥1.5 x10^9/L; bilirubin ≤1.25 x ULN; AST and ALT ≤2.5 x ULN; creatinine clearance ≥30 mL/min or creatinine ≤2.0 mg/dL)
You will not qualify if you...
- Muscle-invasive bladder cancer (stage T2-T4)
- Urothelial carcinoma of upper or lower urinary tract or lymph node metastases
- History of vesicoureteral reflux
- Other malignancies within 2 years except certain cured skin or cervical cancers
- Unresolved toxicities from prior antineoplastic therapy above grade 1
- Uncontrolled infections, respiratory distress, kidney injury, nephrotic syndrome, bladder perforation, or urinary tract obstruction
- Severe or uncontrolled cardiac disease including severe arrhythmias, recent myocardial infarction, or NYHA class III/IV heart failure
- Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg)
- Peripheral neuropathy greater than grade 1
- Known hypersensitivity or prior treatment with docetaxel
- Extensive prior pelvic radiotherapy (>30% bone marrow area)
- Major surgery within 28 days prior to first dose without recovery to grade 2 or better
- Intravesical therapy within 28 days prior to first dose (except immediate chemotherapy after electrode use)
- Recent antitumor therapies within 28 days or 5 half-lives prior to first dose
- Participation in other clinical trials within 28 days or 5 half-lives prior to first dose
- Planned use of other anticancer or investigational drugs during study
- Pregnant or breastfeeding women, or those not using effective contraception
- History of psychiatric disorders, substance abuse, or impairments affecting adherence
- Any condition posing undue risk as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
2
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361102
Completed
3
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Completed
4
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Completed
5
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
6
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China, 300211
Actively Recruiting
Research Team
X
Xiaohua Wei
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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