- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04738630
Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
January 31, 2021 updated by: Taizhou Hanzhong biomedical co. LTD
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
110
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dingwei Ye
- Phone Number: 34778299
- Email: dwyeli@163.com
Study Locations
-
-
Hubei
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Wuhan, Hubei, China, 430030
- Recruiting
- Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
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Wuhan, Hubei, China, 430022
- Recruiting
- Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
-
Contact:
- Xiaoping Zhang
-
-
Hunan
-
Changsha, Hunan, China, 410000
- Recruiting
- Hunan Cancer Hospital
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Contact:
- Weiqing Han
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Dingwei Ye
-
-
Sichuan
-
Chongqing, Sichuan, China, 400016
- Recruiting
- The First Affiliated Hospital of Chongqing Medical University
-
Contact:
- Xin Gou
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: HX008
Participants will receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W)
|
200 mg administered as IV infusion on Day 1 of each 21-day cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complete response (CR) rate
Time Frame: up to approximately 24 months
|
up to approximately 24 months
|
Event-free survival (EFS)
Time Frame: up to approximately 36 months
|
up to approximately 36 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of response (DOR)
Time Frame: up to approximately 36 months
|
up to approximately 36 months
|
Event-free survival (EFS) in the Ta/T1 subset
Time Frame: up to approximately 36 months
|
up to approximately 36 months
|
Progression-free survival (PFS)
Time Frame: up to approximately 36 months
|
up to approximately 36 months
|
Recurrence free survival (RFS)
Time Frame: up to approximately 36 months
|
up to approximately 36 months
|
Overall survival (OS)
Time Frame: up to approximately 36 months
|
up to approximately 36 months
|
Cystectomy-free survival
Time Frame: up to approximately 36 months
|
up to approximately 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 25, 2020
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
January 31, 2021
First Submitted That Met QC Criteria
January 31, 2021
First Posted (Actual)
February 4, 2021
Study Record Updates
Last Update Posted (Actual)
February 4, 2021
Last Update Submitted That Met QC Criteria
January 31, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HX008-II-NMIBC-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bladder Cancer
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage III Bladder Cancer | No Evidence of Disease | Stage II Bladder Cancer | Stage IVA Bladder Cancer | Stage IVB Bladder CancerUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteCompletedMuscle-Invasive Bladder Carcinoma | Bladder Cancer Stage II | Bladder Cancer Stage III | Bladder Cancer Stage IVUnited States
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Fox Chase Cancer CenterTerminatedStage III Bladder Cancer | Distal Urethral Cancer | Proximal Urethral Cancer | Squamous Cell Carcinoma of the Bladder | Urethral Cancer Associated With Invasive Bladder Cancer | Stage II Bladder CancerUnited States
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National Cancer Institute (NCI)TerminatedStage III Bladder Cancer | Stage IV Bladder Cancer | Recurrent Bladder Carcinoma | Bladder Adenocarcinoma | Bladder Squamous Cell Carcinoma | Bladder Urothelial Carcinoma | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
-
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-
Academisch Medisch Centrum - Universiteit van Amsterdam...Bristol-Myers SquibbRecruitingUrinary Bladder Cancer | Invasive Bladder CancerNetherlands
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Taris Biomedical LLCBristol-Myers SquibbTerminatedBladder Cancer TNM Staging Primary Tumor (T) T2 | Bladder Cancer TNM Staging Primary Tumor (T) T2A | Bladder Cancer TNM Staging Primary Tumor (T) T2B | Bladder Cancer TNM Staging Primary Tumor (T) T3 | Bladder Cancer TNM Staging Primary Tumor (T) T3A | Bladder Cancer TNM Staging Primary Tumor... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RecruitingStage 0a Bladder Cancer AJCC v8 | Stage 0is Bladder Cancer AJCC v8 | Stage I Bladder Cancer AJCC v8United States
Clinical Trials on HX008
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Taizhou Hanzhong biomedical co. LTDNot yet recruiting
-
Taizhou Hanzhong biomedical co. LTDUnknown
-
Shanghai Miracogen Inc.RecruitingAdvanced Solid TumorsChina
-
Taizhou Hanzhong biomedical co. LTDUnknown
-
Shanghai Miracogen Inc.RecruitingAdvanced Malignant Solid TumorsChina
-
Taizhou HoudeAoke Biomedical Co., Ltd.Unknown
-
Fudan UniversityRecruitingTreatment EfficacyChina
-
Binhui Biopharmaceutical Co., Ltd.Recruiting
-
Taizhou Hanzhong biomedical co. LTDNot yet recruitingMetastatic Colorectal CancerChina
-
University of OsloThe Research Council of NorwayUnknown