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

NCT06732531 | Recruiting Phase 1

• 2 other identifiers: BH011-I/II-1001CTR20220208
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 6

Brief 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

Bladder Cancer; Non Muscle Invasive

Keywords

BH011; High-Risk Non-Muscle-Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

  From first dose to 30 days after last dose

• 3 month Complete Response Rate (CRR)

  Complete Response rate is defined as the percentage of participants achieving a CR at 3 months post-treatment. It will be measured by determining the percentage of participants without presence of high-grade disease using results from cystoscopy and urine cytology at any time point.

  3 months

Secondary Outcomes (12)

• 6 month Complete Response Rate (CRR)

  6 months

• Recurrence-Free Survival (RFS)

  up to 24 months

• Progression-Free Survival (PFS)

  up to 24 months

• Recurrence-Free Survival Rate

  up to 24 months

• Progression-Free Survival Rate

  up to 24 months

Study Arms (1)

BH011

EXPERIMENTAL

BH011 is administered intravesically through a urinary catheter and is retained in the bladder for 1 hour.

Drug: BH011

Interventions

BH011 DRUG

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.

Also known as: Docetaxel

BH011

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 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 version of the Non-Muscle Invasive Bladder Cancer Guidelines.
• 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;
• 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 muscularis propria tissue in the first resection of the tumour specimen, except for TaLG/G1 tumours or primary carcinoma in situ; and stage T1 bladder tumours. A second TURBT is recommended 2 to 6 weeks after the initial TURBT.
• 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 aminotransferase (ALT) ≤ 2.5× ULN.
• Renal function: creatinine clearance ≥30 mL/min (Cockcroft-Gault formula) or serum creatinine ≤2.0 mg/dL.

You may not qualify 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 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 who have not recovered to Grade 0-1 (CTCAE 5.0) within 3 days prior to the first dose for the following: uncontrolled acute and chronic infections, e.g., pneumonitis, biliary tract infections, hepatitis B virus infections, and hepatitis C virus infections; Respiratory distress; acute and chronic kidney injury; nephrotic syndrome; bladder perforation; urinary tract obstruction.
• 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) history of myocardial infarction, unstable angina pectoris, angioplasty, or coronary artery bridging surgery within 6 months prior to the first dose of the study drug; c) New York Heart Association (NYHA) class III or IV congestive heart failure (see Appendix 4); d) 12-lead electrocardiography: corrected QTc intervals: QTc \> 450 ms in men and QTc \> 470 ms in women (QTc intervals were calculated using the Fridericia formula).
• 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 the first dose.
• Patients who have participated in any other clinical interventional 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 first dose.

Sponsors & Collaborators

• Zhuhai Beihai Biotech Co., Ltd: lead

Study Sites (6)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361102, China

COMPLETED

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

COMPLETED

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

COMPLETED

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Xiaohua Wei

  Zhuhai Beihai Biotech Co., Ltd

  STUDY DIRECTOR

Central Study Contacts

Xiaohua Wei

CONTACT

+86 756 6349669; xhwei@bayhibiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 13, 2024
• Study Start: August 3, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

CN (6)