Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Cancer | Drug: GLS-010 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 89 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open, Multi-center, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Fully Human Anti-PD-1 Monoclonal Antibody (GLS-010 Injection) in Patients With Recurrent or Metastatic Cervical Cancer |
Actual Study Start Date : | May 15, 2019 |
Estimated Primary Completion Date : | May 15, 2022 |
Estimated Study Completion Date : | May 15, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: GLS-010
Full-human anti-pd-1 monoclonal antibodies
|
Drug: GLS-010
Patients will be given 240mg GLS-010 every treatment.
Other Name: Full-human anti-pd-1 monoclonal antibodies
|
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Organ and hematopoietic function as defined below:
Hemoglobin (HGB) ≥ 90 g/L; White blood cell (WBC) ≥ 3 X 109/L; Absolute neutrophil count (ANC) ≥ 1.5 X 109/L; Platelets (PLT) ≥ 100 X 109/L; Total bilirubin≤ 1.5×upper limit of normal (ULN); AST and ALT ≤ 2.5×ULN or, for hepatic dysfunction due to liver metastases, ≤ 5×ULN; Serum creatinine (Cr) ≤ 1.5 X ULN or a creatinine clearance (CrCl) ≥ 50 mL/min; International normalized ratio (INR) or activated partial thromboplastin time (aPTT)≤1.5×ULN;
Exclusion Criteria:
Contact: Xiaohua Wu, MD | 8621-6417 5590 | wu.xh@fudan.edu.cn |
China, Shanghai | |
Fudan University Shanghai Cancer Hospital | Recruiting |
Shanghai, Shanghai, China | |
Contact: Xiaohua Wu, MD 8621-6417 5590 wu.xh@fudan.edu.cn |
Principal Investigator: | Xiaohua Wu, MD | Fudan University |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 31, 2019 | ||||||
First Posted Date ICMJE | June 4, 2019 | ||||||
Last Update Posted Date | June 5, 2019 | ||||||
Actual Study Start Date ICMJE | May 15, 2019 | ||||||
Estimated Primary Completion Date | May 15, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Objective response rate [ Time Frame: within 27 Months after patient enrolled ] Based on an independent image assessment board
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study of GLS-010 Injection in Patients With Recurrent or Metastatic Cervical Cancer | ||||||
Official Title ICMJE | An Open, Multi-center, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Fully Human Anti-PD-1 Monoclonal Antibody (GLS-010 Injection) in Patients With Recurrent or Metastatic Cervical Cancer | ||||||
Brief Summary | Patients with recurrent or metastatic cervical cancer,and will be treated with GLS-010. | ||||||
Detailed Description | Open, uncontrolled, multi-center, phase II study. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
Condition ICMJE | Cervical Cancer | ||||||
Intervention ICMJE | Drug: GLS-010
Patients will be given 240mg GLS-010 every treatment.
Other Name: Full-human anti-pd-1 monoclonal antibodies
|
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Study Arms ICMJE | Experimental: GLS-010
Full-human anti-pd-1 monoclonal antibodies
Intervention: Drug: GLS-010
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
89 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | May 15, 2023 | ||||||
Estimated Primary Completion Date | May 15, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03972722 | ||||||
Other Study ID Numbers ICMJE | YH-S001-05 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Guangzhou Gloria Biosciences Co., Ltd. | ||||||
Study Sponsor ICMJE | Guangzhou Gloria Biosciences Co., Ltd. | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Guangzhou Gloria Biosciences Co., Ltd. | ||||||
Verification Date | May 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |