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出境医 / 临床实验 / Study of GLS-010 Injection in Patients With Recurrent or Metastatic Cervical Cancer (CC)

Study of GLS-010 Injection in Patients With Recurrent or Metastatic Cervical Cancer (CC)

Study Description
Brief Summary:
Patients with recurrent or metastatic cervical cancer,and will be treated with GLS-010.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: GLS-010 Phase 2

Detailed Description:
Open, uncontrolled, multi-center, phase II study.
Study Design
Layout table for study information
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
Arms and Interventions
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

Outcome Measures
Primary Outcome Measures :
  1. Objective response rate [ Time Frame: within 27 Months after patient enrolled ]
    Based on an independent image assessment board


Secondary Outcome Measures :
  1. PFS [ Time Frame: within 27 Months after patient enrolled ]
    meaningful benefit in PFS based on RECIST 1.1

  2. DCR [ Time Frame: within 27 Months after patient enrolled ]
    meaningful benefit in DCR based on RECIST 1.1

  3. DOR [ Time Frame: within 27 Months after patient enrolled ]
    meaningful benefit in DOR based on RECIST 1.1

  4. OS [ Time Frame: within 3 years after patient enrolled. ]
    Overall survival

  5. TTR [ Time Frame: within 27 Months after patient enrolled ]
    meaningful benefit in TTR based on RECIST 1.1


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  1. Willingness to participate in the clinical trial; completely understanding and knowing about the study and signing the ICF; willingness and capability to comply with the requirements of the study.
  2. Female aged from 18 to 75 years (margin included).
  3. Cervical cancer patients with histologically confirmed PD-L1 positive (CPS ≥ 1).
  4. Recurrent or metastatic cervical cancer patients who progress after receiving≥ 1 chemotherapy or are resistant to chemotherapy.
  5. Based on RECIST 1.1, at least one measurable lesions, i.e. an extranodal lesion ≥10 mm in the longest diameter of cross-sectional areas or a lymph node lesion ≥ 15 mm in the shortest diameter of cross-sectional areas in CT or MRI test.
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  7. Life expectancy ≥ 12 weeks.
  8. 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;

  9. Female patients of childbearing potential should be willing to birth control after ICF signing, the course of the study, and 5 months after the last dose of study medication.
  10. Patients must agree to provide either an archival tumor tissue sample or fresh biopsy sample for baseline biomarker tissue analyses, including staining for PD-L1. If archival tissue is not available and the patient does not have biopsy-accessible tumor lesions, the patient will be excluded.

Exclusion Criteria:

  1. Prior therapy with an anti-PD1, anti-PDL1, anti-PDL2, anti-CD137 or anti-CTLA-4 agent (including Ipilimumab or any other drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  2. Prior anti-tumor therapy,(including chemotherapy, targeted small molecule therapy , radiotherapy, immunotherapy, mAb therapy) , or treatment with investigational products having not been launched onto the market in China in other clinical trials within 4 weeks prior to the first dose.
  3. A past history of allergic reactions attributed to any macromolecular protein preparation/monoclonal antibody, or any other composition of the investigational product.
  4. Pregnancy or lactation.
  5. Patients with any autoimmune disease and received systemic therapy within 2 years (i.e. corticosteroids or immunosuppressive medications) [i.e.,but not limited to, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (hypothyroidism without clinical symptoms or caused by radiotherapy and chemotherapy can be included), patients with vitiligo or asthma CR in Childhood, not requiring any intervention in adulthood are permitted to enroll; patients with asthma requiring a bronchiectasis intervention are not permitted to enroll].
  6. Subjects that requires systemic corticosteroids (dose equivalent to or above 10 mg prednisone daily) or other immunosuppressive medications within 14 days prior to enrollment or for the course of the study.
  7. Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  8. Having received a live vaccine within 4 weeks prior to the first dose of investigational drug.
  9. Having received a live anti-tumor vaccine, or anti-tumor treatment with immunostimulation.
  10. Serious medical illness, such as severe infections, uncontrollable diabetes mellitus, cardiovascular diseases (i.e., grade 3 or 4 congestive heart failure (New York Heart Association (NYHA)), ≥ grade 2 heart block, myocardial infarction, uncontrolled arrhythmias, or unstable angina within 6 months prior to screening, and cerebral infarction within 3 months prior to screening) or lung diseases (i.e. interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm).
  11. Patients with positive HBsAg and/or positive HBcAb with positive hepatitis B virus DNA> 103 copies/mL, or positive hepatitis C virus antibody; or positive syphilis.
  12. A known history of human immunodeficiency virus (HIV) infection, or other acquired and congenital immune deficiency diseases.
  13. A known history of active tuberculosis within 1 year prior to the first dose of investigational drug.
  14. Presence of other malignant cancers within 5 years prior to enrollment. Patients with cured carcinoma in situ and cured skin basal cell carcinoma or cutaneous squamous cell carcinoma are eligible.
  15. Having undergone allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
  16. Having undergone major surgery (with the exception of baseline tumor biopsy), or serious trauma within 4 weeks prior to the first dose of therapy.
  17. A history of alcoholism or drug abuse within 1 year.
  18. A clear history of neurological or mental disorders, i.e. epilepsy, dementia, and poor compliance
  19. Patients with other severe, acute or chronic disease that might increase risk of study drug use and participation, or laboratory abnormality that might confound the results of the trial.
  20. Subjects not eligible for the study for other reasons, evaluated by the investigator.
Contacts and Locations

Contacts
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Contact: Xiaohua Wu, MD 8621-6417 5590 wu.xh@fudan.edu.cn

Locations
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China, Shanghai
Fudan University Shanghai Cancer Hospital Recruiting
Shanghai, Shanghai, China
Contact: Xiaohua Wu, MD    8621-6417 5590    wu.xh@fudan.edu.cn   
Sponsors and Collaborators
Guangzhou Gloria Biosciences Co., Ltd.
Investigators
Layout table for investigator information
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
 (submitted: May 31, 2019)
Objective response rate [ Time Frame: within 27 Months after patient enrolled ]
Based on an independent image assessment board
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • PFS [ Time Frame: within 27 Months after patient enrolled ]
    meaningful benefit in PFS based on RECIST 1.1
  • DCR [ Time Frame: within 27 Months after patient enrolled ]
    meaningful benefit in DCR based on RECIST 1.1
  • DOR [ Time Frame: within 27 Months after patient enrolled ]
    meaningful benefit in DOR based on RECIST 1.1
  • OS [ Time Frame: within 3 years after patient enrolled. ]
    Overall survival
  • TTR [ Time Frame: within 27 Months after patient enrolled ]
    meaningful benefit in TTR based on RECIST 1.1
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2019)
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:

  1. Willingness to participate in the clinical trial; completely understanding and knowing about the study and signing the ICF; willingness and capability to comply with the requirements of the study.
  2. Female aged from 18 to 75 years (margin included).
  3. Cervical cancer patients with histologically confirmed PD-L1 positive (CPS ≥ 1).
  4. Recurrent or metastatic cervical cancer patients who progress after receiving≥ 1 chemotherapy or are resistant to chemotherapy.
  5. Based on RECIST 1.1, at least one measurable lesions, i.e. an extranodal lesion ≥10 mm in the longest diameter of cross-sectional areas or a lymph node lesion ≥ 15 mm in the shortest diameter of cross-sectional areas in CT or MRI test.
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  7. Life expectancy ≥ 12 weeks.
  8. 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;

  9. Female patients of childbearing potential should be willing to birth control after ICF signing, the course of the study, and 5 months after the last dose of study medication.
  10. Patients must agree to provide either an archival tumor tissue sample or fresh biopsy sample for baseline biomarker tissue analyses, including staining for PD-L1. If archival tissue is not available and the patient does not have biopsy-accessible tumor lesions, the patient will be excluded.

Exclusion Criteria:

  1. Prior therapy with an anti-PD1, anti-PDL1, anti-PDL2, anti-CD137 or anti-CTLA-4 agent (including Ipilimumab or any other drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  2. Prior anti-tumor therapy,(including chemotherapy, targeted small molecule therapy , radiotherapy, immunotherapy, mAb therapy) , or treatment with investigational products having not been launched onto the market in China in other clinical trials within 4 weeks prior to the first dose.
  3. A past history of allergic reactions attributed to any macromolecular protein preparation/monoclonal antibody, or any other composition of the investigational product.
  4. Pregnancy or lactation.
  5. Patients with any autoimmune disease and received systemic therapy within 2 years (i.e. corticosteroids or immunosuppressive medications) [i.e.,but not limited to, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (hypothyroidism without clinical symptoms or caused by radiotherapy and chemotherapy can be included), patients with vitiligo or asthma CR in Childhood, not requiring any intervention in adulthood are permitted to enroll; patients with asthma requiring a bronchiectasis intervention are not permitted to enroll].
  6. Subjects that requires systemic corticosteroids (dose equivalent to or above 10 mg prednisone daily) or other immunosuppressive medications within 14 days prior to enrollment or for the course of the study.
  7. Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  8. Having received a live vaccine within 4 weeks prior to the first dose of investigational drug.
  9. Having received a live anti-tumor vaccine, or anti-tumor treatment with immunostimulation.
  10. Serious medical illness, such as severe infections, uncontrollable diabetes mellitus, cardiovascular diseases (i.e., grade 3 or 4 congestive heart failure (New York Heart Association (NYHA)), ≥ grade 2 heart block, myocardial infarction, uncontrolled arrhythmias, or unstable angina within 6 months prior to screening, and cerebral infarction within 3 months prior to screening) or lung diseases (i.e. interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm).
  11. Patients with positive HBsAg and/or positive HBcAb with positive hepatitis B virus DNA> 103 copies/mL, or positive hepatitis C virus antibody; or positive syphilis.
  12. A known history of human immunodeficiency virus (HIV) infection, or other acquired and congenital immune deficiency diseases.
  13. A known history of active tuberculosis within 1 year prior to the first dose of investigational drug.
  14. Presence of other malignant cancers within 5 years prior to enrollment. Patients with cured carcinoma in situ and cured skin basal cell carcinoma or cutaneous squamous cell carcinoma are eligible.
  15. Having undergone allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
  16. Having undergone major surgery (with the exception of baseline tumor biopsy), or serious trauma within 4 weeks prior to the first dose of therapy.
  17. A history of alcoholism or drug abuse within 1 year.
  18. A clear history of neurological or mental disorders, i.e. epilepsy, dementia, and poor compliance
  19. Patients with other severe, acute or chronic disease that might increase risk of study drug use and participation, or laboratory abnormality that might confound the results of the trial.
  20. Subjects not eligible for the study for other reasons, evaluated by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiaohua Wu, MD 8621-6417 5590 wu.xh@fudan.edu.cn
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Principal Investigator: Xiaohua Wu, MD Fudan University
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