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Bladder CancerPhase 2NCT04738630

Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer

A Phase 2 study testing HX008 in people with Bladder Cancer, run by Taizhou Hanzhong biomedical co. LTD at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-arm, multicenter study to evaluate the efficacy and safety of HX008 injection in patients with BCG-unresponsive non-muscle invasive bladder cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
HX008
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
5 sitesChina
Study dates
25 Sep 2020to 1 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Be willing and able to provide written informed consent for the trial.
  • Age ≥ 18 years old, male or female.
  • Predominant histologic component (> 50%) must be urothelial (transitional cell) carcinoma.
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.
  • Histologically-confirmed diagnosis of high risk non-muscle invasive bladder cancer (T1, high grade Ta and/or carcinoma in situ [CIS]).
  • BCG-unresponsive high risk non-muscle-invasive bladder cancer, BCG-unresponsive disease as defined as: (a) Persistent or recurrent CIS (+/- recurrent Ta/T1 disease) within 9 months of receiving adequate BCG (at least five of six doses doses of an initial induction course plus either at least two of three doses of maintenance therapy or at least two of six doses of a second induction course); or (b) Recurrent high-grade Ta/T1 disease within 9 months of completion of adequate BCG (at least five of six doses of an initial induction course plus either at least two of three doses of maintenance therapy or at least two of six doses of a second induction course).
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  • Patients must be deemed unfit for radical cystectomy by the treating physician or refuse radical cystectomy.
  • All visible tumor must be completely resected 60 days prior to the first dose of trial treatment. Patients with T1 tumors must undergo a re-staging transurethral resection of bladder tumor (TURBT) within 6 weeks after initial TURBT, and re-staging TURBT must be 60 days prior to the first dose of trial treatment.
  • All patients must have had a cystoscopy without papillary tumor and negative urinary cytology within 21 days prior to the first dose of trial treatment (positive cytology is allowed in patients with CIS component). A cystoscopy is not needed if the TURBT falls within 21 days of prior to the first dose of trial treatment.
  • Patients must have had imaging with X-ray for chest, computed tomography (CT) or magnetic resonance imaging (MRI) for abdomen/pelvis within 90 days prior to the first dose of trial treatment demonstrating no evidence of metastasis.
  • Willing to provide tissue specimens.
  • Has adequate organ function as defined in the protocol.
  • Male subjects must agree to use effective contraceptives during treatment and for at least 120 days after the last treatment.
  • Women of childbearing age must have a negative pregnancy test within 72 hours before the first dose of trial treatment, and agree to use effective contraceptives during treatment and for at least 120 days after the last treatment.

Who cannot join

  • Muscle-invasive or metastatic urothelial carcinoma.
  • Concurrent extra-vesical (i.e., urethra, ureter, or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
  • Patients who had a malignant tumor other than urothelial carcinoma of the bladder within the first 5 years of enrolment. The following can be included: a. low-risk localized prostate cancer (staging ≤ T2B, Gleason score ≤7, PSA≤20ng/mL, no recurrence after treatment (as determined by PSA level)); b. low-risk prostate cancer (T1/ T2A, Gleason score ≤7, and PSA≤10ng/mL) who were not treated and under observation; c. patients with very low risk metastasis or death of malignant tumor (5-year metastasis or death risk< 5%), showed no recurrence after standard treatment, such as cervical cancer in situ, basal or squamous cell skin cancer, etc.
  • Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4, or anti-4-1BB agents.
  • Has received systemic chemotherapy or immunotherapy, or radiation therapy for bladder cancer.
  • Patients with active autoimmune disease that has required systemic treatment in past 2 years.
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  • Has received a major surgery within 4 weeks prior to the first dose of trial treatment.
  • Has a history of testing positive for human immunodeficiency virus (HIV), or known acquired immunodeficiency syndrome (AIDS), or stem cell transplantation or organ transplantation.
  • Patients with active chronic hepatitis B or active hepatitis C. Patients with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA below the threshold of the test standard of each center), and cured hepatitis C can be enrolled.
  • Has received system treatment with corticosteroids (dose >10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.
  • Has a history of active tuberculosis.
  • Has a history or current interstitial pneumonia, or current non--infectious pneumonitis.
  • Has uncontrolled systemic disease, such as diabetes or hypertension.
  • Has cardiac dysfunction (grade III-IV according to NYHA) and significant pulmonary disease (such as shortness of breath at rest or minor activity or the need for oxygen for any reason) prior to the first dose of trial treatment.
  • Patients with other disease, or metabolic disorder, or abnormal physical examination or laboratory test, or anticipated to cause complications with trial treatment.
  • Has a severe infection prior to the first dose of trial treatment.
  • Has a history of severe allergic reaction to any other monoclonal antibodies.
  • Has participated in other anticancer drug clinical trials within 4 weeks.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
  • Has received a live vaccine within 30 days prior to the first dose of trial treatment.
  • According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Trial locations and contacts

5 sites in 1 country.

Dingwei Ye contact

34778299

dwyeli@163.com

5 sites in 1 country

China5 sites, 5 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Weiqing Han

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Sichuan, 400016

    Xin Gou

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Dingwei Ye

    Recruiting

  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of science and technology

    Wuhan, Hubei, 430022

    Xiaoping Zhang

    Recruiting

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology

    Wuhan, Hubei, 430030

    Zhiquan Hu

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Open-lable, Multicenter, Phase II Clinical Study of HX008 in Subjects With BCG-Unresponsive Non-muscle Invasive Bladder Cancer

This is a single-arm, multicenter study to evaluate the efficacy and safety of HX008 injection in patients with BCG-unresponsive non-muscle invasive bladder cancer.

Conditions
Bladder Cancer
Being tested
HX008
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.

  • HX008Drug

    200 mg administered as IV infusion on Day 1 of each 21-day cycle.

Study groups in NCT04738630
Study groupRoleWhat they receive
Experimental: HX008ExperimentalParticipants will receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W)
Receives: Drug: HX008

What is being measured

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

  1. Complete response (CR) rate

    Measured: up to approximately 24 months

  2. Event-free survival (EFS)

    Measured: up to approximately 36 months

Secondary outcomes (6)

  1. Duration of response (DOR)

    Measured: up to approximately 36 months

  2. Event-free survival (EFS) in the Ta/T1 subset

    Measured: up to approximately 36 months

  3. Progression-free survival (PFS)

    Measured: up to approximately 36 months

  4. Recurrence free survival (RFS)

    Measured: up to approximately 36 months

  5. Overall survival (OS)

    Measured: up to approximately 36 months

  6. Cystectomy-free survival

    Measured: up to approximately 36 months

Timeline

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

  1. First posted4 Feb 2021
  2. Study start25 Sep 2020
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion1 Dec 2023 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04738630
Sponsor's protocol ID
HX008-II-NMIBC-01
Status last verified
Jan 2021
First submitted
31 Jan 2021
Last updated
4 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HX008 in people with Bladder Cancer, run by Taizhou Hanzhong biomedical co. LTD at 5 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 14 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 phase mean?

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?

Results are not available in the source record.

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

Contact Dingwei Ye (34778299, dwyeli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (CR) rate (time frame: up to approximately 24 months). 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 NCT04738630.

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 4 Feb 2021.

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