OncoMatch/Clinical Trials/NCT06732531
Safety, Tolerability, and Preliminary Efficacy of BH011 in Subjects With Non-Muscle-Invasive Bladder Cancer
Is NCT06732531 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies BH011 for bladder cancer.
Treatment: BH011 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: BCG therapy — intravesical
Patients who had failed intravesical administration of BCG prior to enrolment and were not candidates for or refused radical cystectomy. BCG failures included BCG refractory, recurrence after BCG, BCG non-responsive, and BCG intolerant
Cannot have received: docetaxel (docetaxel)
Patients with known or suspected hypersensitivity to docetaxel, its excipients or similar drugs. Patients previously treated with docetaxel
Cannot have received: extensive pelvic radiotherapy
Patients with previous extensive radiotherapy to the pelvis (radiotherapy > 30% of the bone marrow area)
Cannot have received: intravesical therapy
Exception: immediate chemotherapy infusion after previous and current electrodes is permitted
Patients who have received intravesical therapy within 28 days prior to the first dose (immediate chemotherapy infusion after previous and current electrodes is permitted)
Cannot have received: antitumor therapy
Patients receiving antitumor therapy such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, biologic therapy, and herbal medicine within 28 days or 5 half-lives of the drug, whichever is longer, prior to the first dose
Lab requirements
Blood counts
hemoglobin (HGB) ≥80 g/L, platelet count (PLT) ≥100×10^9/L, absolute neutrophil count (ANC) ≥1.5×10^9/L
Kidney function
creatinine clearance ≥30 mL/min (Cockcroft-Gault formula) or serum creatinine ≤2.0 mg/dL
Liver function
serum total bilirubin ≤ 1.25 x ULN (or 2.5 × ULN in case of constitutional hepatic dysfunction jaundice [Gilbert's syndrome]), AST and ALT ≤ 2.5× ULN
Cardiac function
No severe or uncontrolled cardiac disease requiring treatment, including: severe arrhythmias (ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block, etc.); history of myocardial infarction, unstable angina pectoris, angioplasty, or coronary artery bridging surgery within 6 months prior to the first dose; NYHA class III or IV congestive heart failure; 12-lead ECG: QTc > 450 ms in men and QTc > 470 ms in women (Fridericia formula)
The major organs are functioning well, i.e. the following criteria are met: Bone marrow function: hemoglobin (HGB) ≥80 g/L, platelet count (PLT) ≥100×10^9/L, absolute neutrophil count (ANC) ≥1.5×10^9/L. Liver function: serum total bilirubin ≤ 1.25 x ULN (or 2.5 × ULN in case of constitutional hepatic dysfunction jaundice [Gilbert's syndrome]), AST and ALT ≤ 2.5× ULN. Renal function: creatinine clearance ≥30 mL/min (Cockcroft-Gault formula) or serum creatinine ≤2.0 mg/dL. Cardiac: see exclusion criteria for details.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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