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Phase I Clinical Trial in Chinese Patients of Advanced and (or) Recurrent Solid Tumor/Lymphoma (GB226)

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ClinicalTrials.gov Identifier: NCT03374007
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Genor Biopharma Co., Ltd.

Tracking Information
First Submitted Date  ICMJE December 6, 2017
First Posted Date  ICMJE December 14, 2017
Last Update Posted Date December 18, 2019
Actual Study Start Date  ICMJE October 19, 2017
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
  • adverse event [ Time Frame: all adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment. ]
    adverse event
  • Serious Adverse Event [ Time Frame: all serious adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment. ]
    Serious Adverse Event
  • Dose limiting Toxicity, DLT [ Time Frame: Day 1 to Day 28 after first dose ]
    Dose limiting Toxicity, DLT
  • Maximum Tolerated Dose, MTD [ Time Frame: Day 1 to Day 28 after first dose ]
    Maximum Tolerated Dose, MTD
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
  • AE [ Time Frame: all adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment. ]
    adverse event
  • SAE [ Time Frame: all serious adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment. ]
    Serious Adverse Event
  • DLT [ Time Frame: Day 1 to Day 28 after first dose ]
    Dose limiting Toxicity
  • MTD [ Time Frame: Day 1 to Day 28 after first dose ]
    Maximum Tolerated Dose
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
  • AUC 0-t [ Time Frame: up to 12 weeks ]
    AUC 0-t
  • C max [ Time Frame: up to 12 weeks ]
    C max
  • AUC 0-∞ [ Time Frame: up to 12 weeks ]
    AUC 0-∞
  • T max [ Time Frame: up to 12 weeks ]
    T max
  • Vd [ Time Frame: up to 12 weeks ]
    Vd
  • Ke [ Time Frame: up to 12 weeks ]
    Ke
  • t 1/2 [ Time Frame: up to 12 weeks ]
    t 1/2
  • CL [ Time Frame: up to 12 weeks ]
    CL
  • Anti-drug antibody, ADA [ Time Frame: up to 12 weeks ]
    Anti-drug antibody, ADA
  • IFN-γ concentration [ Time Frame: up to 12 weeks ]
    IFN-γ concentration
  • peripheral blood CD8+PD-1 receptor occupying ratio [ Time Frame: up to 12 weeks ]
    peripheral blood CD8+PD-1 receptor occupying ratio
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Clinical Trial in Chinese Patients of Advanced and (or) Recurrent Solid Tumor/Lymphoma
Official Title  ICMJE With Open, Single/Multiple Dosing and Dose Escalation, Phase I Clinical Trial Scheme to Evaluate Safety, Tolerance and Pharmacokinetic Properties of Genolimzumab Injection
Brief Summary With open, single/ multiple dosing and dose escalation, phase I clinical trial scheme to evaluate safety, tolerance and pharmacokinetic properties of Genolimzumab injection in Chinese patients of advanced and (or) recurrent solid tumor/lymphoma
Detailed Description Recombinant Programmed death-1(PD-1) humanized monoclonal antibody injection (company code: GB226) is joint developed by Genor Biopharma Co. Ltd and Crown Bioscience,Inc., it is the reorganization of deoxyribonucleic acid (DNA) technology in the Chinese hamster ovary (CHO) cells express system expressed in a immunoglobulin G4 (IgG4) kappa type single resistance to predominate. GB226 had the different new amino acid sequence and molecular structure compared with two marketed PD-1 monoclonal antibody injection and got the approval of China Food and Drug Administration (CFDA) for clinical trial.Pharmaceutical research indicated GB226 cell strain had security source, production process is stable, quality can control, preparation stability, has good compatibility with packaging materials, it has the condition of industrialization, can prepare investigational medicinal product with safety, effective, and controlled quality for clinical research.Pharmacodynamics study show the targets and mechanisms of GB226 is clear, tumor suppression effect is obvious.Toxicology studies show this product in high doses with low toxic, and the toxic is reversible, the most common toxicity is specific to the drug action mechanism.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumor
  • Recurrent Solid Tumor
  • Lymphoma
  • Recurrent Lymphocyte Depleted Classical Hodgkin Lymphoma
Intervention  ICMJE
  • Biological: Geptanolimab Injection 1mg/kg
    single-dose:1mg/kg
    Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
  • Biological: Geptanolimab Injection 3mg/kg
    single-dose: 3mg/kg
    Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
  • Biological: Geptanolimab Injection 10mg/kg
    single-dose:10mg/kg
    Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
  • Biological: Geptanolimab Injection 1mg/kg, q2w*6
    multiple dosing: 1mg/kg, q2w*6
    Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
  • Biological: Geptanolimab Injection 3mg/kg, q2w*6
    multiple dosing: 3mg/kg, q2w*6
    Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
  • Biological: Geptanolimab Injection 10mg/kg, , q2w*6
    multiple dosing: 10mg/kg, , q2w*6
    Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
  • Biological: Geptanolimab Injection 280mg, q3w
    multiple dosing: 280mg, q3w
    Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
  • Biological: Geptanolimab Injection 3mg/kg, q2w
    multiple dosing: 3mg/kg, q2w
    Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
Study Arms  ICMJE
  • Experimental: GB226 1mg/kg single-dose
    Geptanolimab, 1mg/kg, i.v., single-dose
    Intervention: Biological: Geptanolimab Injection 1mg/kg
  • Experimental: GB226 3 mg/kg single-dose
    Geptanolimab, 3mg/kg, i.v., single-dose
    Intervention: Biological: Geptanolimab Injection 3mg/kg
  • Experimental: GB226 10mg/kg single-dose
    Geptanolimab 10mg/kg, i.v., single-dose
    Intervention: Biological: Geptanolimab Injection 10mg/kg
  • Experimental: GB226 1mg/kg multiple dosing, every 2 weeks
    Geptanolimab, 1mg/kg, i.v., q2w*6
    Intervention: Biological: Geptanolimab Injection 1mg/kg, q2w*6
  • Experimental: GB226 3mg/kg multiple dosing,every 2 weeks
    Geptanolimab, 3mg/kg, i.v., q2w*6
    Intervention: Biological: Geptanolimab Injection 3mg/kg, q2w*6
  • Experimental: GB226 10mg/kg multiple dosing, every 2 weeks
    Geptanolimab,10mg/kg, i.v., q2w*6
    Intervention: Biological: Geptanolimab Injection 10mg/kg, , q2w*6
  • Experimental: GB226 280mg multiple dosing
    Geptanolimab, 280mg, i.v., q3w
    Intervention: Biological: Geptanolimab Injection 280mg, q3w
  • Experimental: GB226 3mg/kg multiple dosing
    Geptanolimab, 3mg/kg, i.v., q2w
    Intervention: Biological: Geptanolimab Injection 3mg/kg, q2w
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: December 11, 2017)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Age: 18-65. Unisex.
  • 2. Understand trial procedure and content and sign informed consent voluntarily;
  • 3. Patients of advanced (phase Ⅲb, multidisciplinary treatment is not appropriate), metastatic (phase IV) or recurrent solid tumor (including melanoma, NSCLC, renal cell carcinoma, head & neck cancer, esophagus cancer, liver cancer, bladder cancer, spongioblastoma) or lymphoma (classical hodgkin lymphoma and (or) peripheral T-cell lymphoma, natural killer (NK)-T cell lymphoma and mediastinal B cell lymphoma) conformed by histology or cytology and cannot be cured by surgery. There is no effective standard treatment now.
  • 4. Agree to provide recorded tumor tissue sample or fresh tissue sample.
  • 5. Eastern Cooperative Oncology Group (ECOG): 0-1;
  • 6. Expected life ≥ 3 months;
  • 7. With at least one measurable and evaluable tumor (solid tumor is subject to criteria for evaluating efficacy of Immune-Related Response Criteria (irRC)/RECIST and lymphoma is subject to criteria/revised criteria of international working group);
  • 8. Chemotherapy of the whole body is completed at least 4 weeks before inclusion.
  • 9. Radiotherapy of the whole body and partial palliative radiotherapy are completed at least 4 weeks before inclusion.
  • 10. Corticosteroids (prednisone>10mg/d or equivalent) has been stopped at least 2 weeks before inclusion.
  • 11. Autotransplantation is completed at least 3 months before inclusion.
  • 12. Major surgeries with the need of general anesthesia are completed at least 4 weeks. Surgeries with the need of local anesthesia/epidural anesthesia are completed at least 2 weeks and the subjects have recovered. Skin biopsies with the need of local anesthesia are completed at least 1 hour before inclusion.
  • 13. Previous tumor biotherapy (tumor vaccine, cell factor or growth factor for the purpose of tumor control) is completed at least 4 weeks before inclusion;
  • 14. Without severe haematological, cardiopulmonary, liver and kidney diseases except protopathic. For patients of solid tumor, hemoglobin≥9g/dl, neutrophile granulocyte≥1.5×109/L, blood platelet≥100×1012/L. For patients of hematologic tumor, hemoglobin≥8g/dl, neutrophile granulocyte≥1.0×109/L, blood platelet≥80×1012/L.
  • 15. Serum creatinine≤1.5xUpper Limit Of Normal (ULN) or creatinine clearance rate≥50mL/min and urine protein<2+ in test paper of urine. For patients with urine protein great than or equal to 2+ in test paper of urine, urine shall be collected in 24 hours and urine protein must less than or be equal to 1g.

etc.

Exclusion Criteria:

  • 1. Active central nervous system metastasis; If central nervous system (CNS) metastasis of patients can be treated and their symptoms of nervous system can recover to the baseline level (excluding residual signs or symptoms related to CNS treatment) for 2 weeks when they are included, they can participate in the research. Cranial CT or MRI scanning shall be made for the patients 30 days before inclusion.
  • 2. Meningeal metastases or meningeal infiltration of tumors;
  • 3. Patients with other malignant tumors (excluding cured cervical carcinoma in situ and skin basal cell carcinoma) shall not participate in the research, unless he/she has been fully relieved at least 2 years without the need of other treatment or other treatment is not needed during the research.
  • 4. With active, known or suspected autoimmune disease.
  • 5. With previous usage of PD-1 antibody, PD-L1 antibody, PD-L2 antibody or cytotoxic T-lymphocyte-associated antigen-4 immunoglobulin (CTLA-4) antibody for treatment (or other antibody for co-stimulation or check point assess of T cells)
  • 6.With severe internal medicine diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, active peptic ulcer, active bleeding.
  • 7. With active infection.
  • 8. With active tuberculosis infection; with active tuberculosis infection in the past.
  • 9. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) and treponema pallidum antibody (TP-Ab). Positive subjects of HBsAg may not be excluded from patients of liver cancer.
  • 10. Complication with the need of immunosuppressive drug or complication with the need of corticosteroids for whole or partial body in the dosage of immunosuppressive action.

etc.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shawn Yu, Master 86-010-65260820 shawn.yu@genorbio.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03374007
Other Study ID Numbers  ICMJE Gxplore-001
Has Data Monitoring Committee No
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
Plan to Share IPD: No
Plan Description: There is not a plan to make individual participant data available.
Responsible Party Genor Biopharma Co., Ltd.
Study Sponsor  ICMJE Genor Biopharma Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yuankai Shi, Doctor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
PRS Account Genor Biopharma Co., Ltd.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP