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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Recurrent Solid Tumor Lymphoma Recurrent Lymphocyte Depleted Classical Hodgkin Lymphoma Biological: Geptanolimab Injection 1mg/kg Biological: Geptanolimab Injection 3mg/kg Biological: Geptanolimab Injection 10mg/kg Biological: Geptanolimab Injection 1mg/kg, q2w*6 Biological: Geptanolimab Injection 3mg/kg, q2w*6 Biological: Geptanolimab Injection 10mg/kg, , q2w*6 Biological: Geptanolimab Injection 280mg, q3w Biological: Geptanolimab Injection 3mg/kg, q2w Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: With Open, Single/Multiple Dosing and Dose Escalation, Phase I Clinical Trial Scheme to Evaluate Safety, Tolerance and Pharmacokinetic Properties of Genolimzumab Injection
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: GB226 1mg/kg single-dose
Geptanolimab, 1mg/kg, i.v., single-dose
Biological: Geptanolimab Injection 1mg/kg
single-dose:1mg/kg
Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection

Experimental: GB226 3 mg/kg single-dose
Geptanolimab, 3mg/kg, i.v., single-dose
Biological: Geptanolimab Injection 3mg/kg
single-dose: 3mg/kg
Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection

Experimental: GB226 10mg/kg single-dose
Geptanolimab 10mg/kg, i.v., single-dose
Biological: Geptanolimab Injection 10mg/kg
single-dose:10mg/kg
Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection

Experimental: GB226 1mg/kg multiple dosing, every 2 weeks
Geptanolimab, 1mg/kg, i.v., q2w*6
Biological: Geptanolimab Injection 1mg/kg, q2w*6
multiple dosing: 1mg/kg, q2w*6
Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection

Experimental: GB226 3mg/kg multiple dosing,every 2 weeks
Geptanolimab, 3mg/kg, i.v., q2w*6
Biological: Geptanolimab Injection 3mg/kg, q2w*6
multiple dosing: 3mg/kg, q2w*6
Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection

Experimental: GB226 10mg/kg multiple dosing, every 2 weeks
Geptanolimab,10mg/kg, i.v., q2w*6
Biological: Geptanolimab Injection 10mg/kg, , q2w*6
multiple dosing: 10mg/kg, , q2w*6
Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection

Experimental: GB226 280mg multiple dosing
Geptanolimab, 280mg, i.v., q3w
Biological: Geptanolimab Injection 280mg, q3w
multiple dosing: 280mg, q3w
Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection

Experimental: GB226 3mg/kg multiple dosing
Geptanolimab, 3mg/kg, i.v., q2w
Biological: Geptanolimab Injection 3mg/kg, q2w
multiple dosing: 3mg/kg, q2w
Other Name: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection




Primary Outcome Measures :
  1. 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

  2. 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

  3. Dose limiting Toxicity, DLT [ Time Frame: Day 1 to Day 28 after first dose ]
    Dose limiting Toxicity, DLT

  4. Maximum Tolerated Dose, MTD [ Time Frame: Day 1 to Day 28 after first dose ]
    Maximum Tolerated Dose, MTD


Secondary Outcome Measures :
  1. AUC 0-t [ Time Frame: up to 12 weeks ]
    AUC 0-t

  2. C max [ Time Frame: up to 12 weeks ]
    C max

  3. AUC 0-∞ [ Time Frame: up to 12 weeks ]
    AUC 0-∞

  4. T max [ Time Frame: up to 12 weeks ]
    T max

  5. Vd [ Time Frame: up to 12 weeks ]
    Vd

  6. Ke [ Time Frame: up to 12 weeks ]
    Ke

  7. t 1/2 [ Time Frame: up to 12 weeks ]
    t 1/2

  8. CL [ Time Frame: up to 12 weeks ]
    CL

  9. Anti-drug antibody, ADA [ Time Frame: up to 12 weeks ]
    Anti-drug antibody, ADA

  10. IFN-γ concentration [ Time Frame: up to 12 weeks ]
    IFN-γ concentration

  11. peripheral blood CD8+PD-1 receptor occupying ratio [ Time Frame: up to 12 weeks ]
    peripheral blood CD8+PD-1 receptor occupying ratio



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374007


Contacts
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Contact: Shawn Yu, Master 86-010-65260820 shawn.yu@genorbio.com

Locations
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China, Beijing
Cancer Hospital Chinese Academy of Medical Sciences Not yet recruiting
Beijing, Beijing, China, 100021
Contact: Yuankai Shi, Doctor         
Principal Investigator: Yuankai Shi, Doctor         
China, Heilongjiang
Harbin Medical University Cancer Hospital Recruiting
Harbin, Heilongjiang, China, 150081
Contact: Qingyuan Zhang, Doctor         
Principal Investigator: Qingyuan Zhang, Doctor         
Sponsors and Collaborators
Genor Biopharma Co., Ltd.
Investigators
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Principal Investigator: Yuankai Shi, Doctor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Genor Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT03374007    
Other Study ID Numbers: Gxplore-001
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make individual participant data available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents