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Tests treatment safety and results for Bladder Cancer
Official title Safety, Tolerability, and Preliminary Efficacy of BH011 in Subjects With Non-Muscle-Invasive Bladder Cancer
ClinicalTrials.gov ID: NCT06732531
What this study is testing
What is BH011?
BH011 is an investigational medicine, given as an once-weekly, being studied as a potential treatment for bladder cancer.
Also referred to as Docetaxel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people were fully informed about the study and voluntarily signed an informed consent form and were willing to complete the trial in accordance with...
- Male or female, ≥18 years of age at time of informed consent.
- First TURBT completed within 12 weeks prior to the first dose, histologically confirmed diagnosis of non-muscle invasive bladder cancer and...
- Patients who had failed intravesical administration of BCG prior to enrolment and were not candidates for or refused radical cystectomy.BCG failures...
- After TURBT, it is confirmed that the tumour has been completely removed from the bladder. A second TURBT is required for the following: confirmed or...
You likely can't join if
- Patients with muscle-invasive bladder cancer (T2-T4).
- Patients with urothelial carcinoma of the upper or lower urinary tract, and/or lymph node metastases.
- Patients with a history of vesicoureteral reflux.
- Patients with other malignancies within 2 years, except locally curable (cured) cancers, e.g. basal cell carcinoma of the skin, squamous cell...
- Patients who have not recovered (toxicity assessment remains \> Grade 1 or has not recovered to baseline levels) from toxic reactions (other than...
- Patients with severe or uncontrolled cardiac disease requiring treatment, including: a) severe arrhythmias (ventricular arrhythmias requiring...
See the full eligibility criteria
- people were fully informed about the study and voluntarily signed an informed consent form and were willing to complete the trial in accordance with the protocol process.
- Male or female, ≥18 years of age at time of informed consent.
- First TURBT completed within 12 weeks prior to the first dose, histologically confirmed diagnosis of non-muscle invasive bladder cancer and classified as high risk according to the European Association of Urology 2020...
- 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...
- After TURBT, it is confirmed that the tumour has been completely removed from the bladder. A second TURBT is required for the following: confirmed or suspected incomplete resection of the tumour by TURBT; absence of...
- Eastern Cooperative Oncology Group (ECOG) score 0 to 1.
- Expected survival ≥ 6 months.
- The major organs are functioning well, i.e. the following criteria are met:
- Bone marrow function: hemoglobin (HGB) ≥80 g/L, platelet count (PLT) ≥100×109/L, absolute neutrophil count (ANC) ≥1.5×109/L.
- Liver function: serum total bilirubin ≤ 1.25 x upper limit of normal (ULN) (or 2.5 × ULN in case of constitutional hepatic dysfunction jaundice [Gilbert's syndrome]), aspartate aminotransferase (AST) and alanine...
- Renal function: creatinine clearance ≥30 mL/min (Cockcroft-Gault formula) or serum creatinine ≤2.0 mg/dL.
- Patients with muscle-invasive bladder cancer (T2-T4).
- Patients with urothelial carcinoma of the upper or lower urinary tract, and/or lymph node metastases.
- Patients with a history of vesicoureteral reflux.
- Patients with other malignancies within 2 years, except locally curable (cured) cancers, e.g. basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix.
- Patients who have not recovered (toxicity assessment remains \> Grade 1 or has not recovered to baseline levels) from toxic reactions (other than malaise, alopecia) associated with prior antineoplastic therapy; patients...
- Patients with severe or uncontrolled cardiac disease requiring treatment, including: a) severe arrhythmias (ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block, etc.); b)...
- Patients with uncontrolled hypertension on treatment (defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg).
- Patients with peripheral neuropathy \> grade 1.
- Patients with known or suspected hypersensitivity to docetaxel, its excipients or similar drugs.
- Patients previously treated with docetaxel.
- Patients with previous extensive radiotherapy to the pelvis (radiotherapy \> 30% of the bone marrow area).
- Patients who have undergone major surgical treatment within 28 days prior to the first dose, or who have failed to recover to ≤ grade 2 from adverse effects of any such procedure.
- Patients who have received intravesical therapy within 28 days prior to the first dose (immediate chemotherapy infusion after previous and current electrodes is permitted).
- 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...
- Patients who have participated in any other clinical treatment trial treatment (other than patients enrolled in a study with overall survival follow-up) within 28 days or 5 half-lives, whichever is longer, prior to the...
- Patients who plan to receive other anticancer treatments or other investigational drugs during the study period.
- Pregnant or breastfeeding female patients. Positive blood pregnancy test in females of childbearing potential within 7 days prior to first dose; Any male and female patient of childbearing potential refuses to use a...
- Has had a hysterectomy or bilateral oophorectomy, or
- Medically diagnosed with ovarian failure, or
- Medically diagnosed as post-menopausal (menopause for at least 12 consecutive months in the absence of pathologic or physiologic causes).
- Patients with known history of psychiatric disorders, substance abuse, drug and alcohol addiction, and impairments in adherence.
- Any other patients who, in the opinion of the investigator, would result in unnecessary risk to the subject and are therefore unsuitable for participation in this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Xiamen, Fujian, China
- Changsha, Hunan, China
- Shenyang, Liaoning, China
- Shanghai, Shanghai Municipality, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Xiamen, Fujian, China; Changsha, Hunan, China; Shenyang, Liaoning, China; Shanghai, Shanghai Municipality, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.