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Bladder CancerPhase 1/2NCT06732531

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

A Phase 1/2 study testing BH011 in people with Bladder Cancer and Non Muscle Invasive, run by Zhuhai Beihai Biotech Co., Ltd at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer, Non Muscle Invasive
What is being tested?
BH011
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
6 sitesChina
Study dates
3 Aug 2022to Dec 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.
  • 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 contraceptive method with an annual failure rate of <1% (contraceptive methods with an annual failure rate of <1% include bilateral tubal ligation, male sterilization, proper use of hormonal contraceptives that suppress ovulation, hormone-releasing intrauterine devices (IUDs), and copper-containing IUDs, or condoms) throughout the duration of the trial and for a period of 30 days after the last study dose. In the judgment of the investigators, a patient is defined as having the ability to procreate as he/she is biologically capable of having children as well as having a normal sex life. Female patients who are not of childbearing potential (i.e., meet at least 1 of the following criteria):
  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaohua Wei contact

+86 756 6349669

xhwei@bayhibiotech.com

6 sites in 1 country

China6 sites, 3 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Zhisong He, MD, +86 010-83572600

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Completed

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Dingwei Ye, MD, +86 021-175590

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    Completed

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

    Hailong Hu, MD, +86 022-88328832

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361102

    Completed

Other trials in China

About this study

Official title: A Phase I/II, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of BH011 in Subjects With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer After Bacillus Calmette-Guérin

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.

Read the detailed description

The plan is to study the safety and preliminary efficacy of BH011 in High-Risk NMIBC patients who failed BCG therapy. Most patients with NMIBC is (Cis, Cis with Ta and/or T1, high grade Ta or T1 with frequent or uncontrolled recurrences) who have failed BCG intravesical therapy (standard of care) usually have no other choice but to proceed to cystectomy. Cystectomy is a surgery associated with major morbidity, mortality and quality of life issues. Morbidity and long term tedious medical care will be for the rest of the patient's life span. Most patients at this stage do not show signs of disease progression into the muscle layer or of metastasis, making surgery a very difficult decision. BH011 will serve to provide a therapeutic alternative for this patient population in need.

In this study, patients will begin treatment with BH011 2-8 weeks after TURBT and will be administered once weekly for 6 weeks during the induction treatment period and once monthly for 12 months in the maintenance treatment period. Patients will undergo cystoscopy, urine cytology, and biopsy every 3 months for up to 24 months to confirm clinical efficacy.

Being tested
BH011
Keywords
BH011, High-Risk Non-Muscle-Invasive Bladder Cancer
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BH011Drug

    Also called Docetaxel

    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.

Study groups in NCT06732531
Study groupRoleWhat they receive
BH011ExperimentalBH011 is administered intravesically through a urinary catheter and is retained in the bladder for 1 hour.
Receives: Drug: BH011

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events

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

    Measured: From first dose to 30 days after last dose

  2. 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.

    Measured: 3 months

Secondary outcomes (12)

  1. 6 month Complete Response Rate (CRR)

    Complete Response rate is defined as the percentage of participants achieving a CR at 6 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.

    Measured: 6 months

  2. Recurrence-Free Survival (RFS)

    RFS is defined as the time from the first study treatment to the presentation of the first pathologically confirmed high-risk non-muscle invasive bladder cancer (T1, CIS, or high-grade Ta) recurrence or death from any cause, whichever occurred earliest.

    Measured: up to 24 months

  3. Progression-Free Survival (PFS)

    PFS is defined as the time from the first study treatment to the occurrence of the first bladder cancer infiltration into the muscularis propria, lymphatic metastasis, distant metastasis, or death from any cause, whichever occurred earliest.

    Measured: up to 24 months

  4. Recurrence-Free Survival Rate

    The RFS rate is defined as the rate of subjects without pathologically confirmed high-risk non-muscle invasive bladder cancer (T1, CIS, or high-grade Ta) recurrence or death from any cause.

    Measured: up to 24 months

  5. Progression-Free Survival Rate

    The PFS rate is defined as the rate of subjects free of bladder cancer infiltration into the muscularis propria, lymphatic metastasis, distant metastasis, or death from any cause.

    Measured: up to 24 months

  6. Pharmacokinetic of BH011

    Maximum Concentration (Cmax)

    Measured: Weeks 1 and 6 of dosing

  7. Pharmacokinetic of BH011

    Time to Cmax (Tmax)

    Measured: Weeks 1 and 6 of dosing

  8. Pharmacokinetic of BH011

    Area Under the Curve From Time 0 Hours to Last Quantifiable Concentration (AUC0-last)

    Measured: Weeks 1 and 6 of dosing

  9. Pharmacokinetic of BH011

    Area Under the Curve From Time 0 Hours to Infinity (AUC0-inf)

    Measured: Weeks 1 and 6 of dosing

  10. Pharmacokinetic of BH011

    Apparent Terminal Elimination Half-Life (t1/2)

    Measured: Weeks 1 and 6 of dosing

  11. Pharmacokinetic of BH011

    Apparent Total Clearance (CL)

    Measured: Weeks 1 and 6 of dosing

  12. Pharmacokinetic of BH011

    Apparent Volume of Distribution (Vz/F)

    Measured: Weeks 1 and 6 of dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2024
  2. Study start3 Aug 2022
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06732531
Sponsor's protocol ID
BH011-I/II-1001
Other IDs
CTR20220208
Status last verified
Jan 2025
First submitted
9 Dec 2024
Last updated
9 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BH011 in people with Bladder Cancer and Non Muscle Invasive, run by Zhuhai Beihai Biotech Co., Ltd at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaohua Wei (+86 756 6349669, xhwei@bayhibiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: From first dose to 30 days after last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06732531.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.

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