| 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 | |||||||
|---|---|---|---|---|---|---|---|
| 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
|
||||||
| 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 |
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