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

NCT ID: NCT03374007

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-19
• Study Completion Date: 2022-08-31

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.

Conditions

Advanced Solid Tumor; Recurrent Solid Tumor; Lymphoma; Recurrent Lymphocyte Depleted Classical Hodgkin Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GB226 1mg/kg single-dose

Geptanolimab, 1mg/kg, i.v., single-dose

Group Type: EXPERIMENTAL

Geptanolimab Injection 1mg/kg

Intervention Type: BIOLOGICAL

single-dose:1mg/kg

GB226 3 mg/kg single-dose

Geptanolimab, 3mg/kg, i.v., single-dose

Group Type: EXPERIMENTAL

Geptanolimab Injection 3mg/kg

Intervention Type: BIOLOGICAL

single-dose: 3mg/kg

GB226 10mg/kg single-dose

Geptanolimab 10mg/kg, i.v., single-dose

Group Type: EXPERIMENTAL

Geptanolimab Injection 10mg/kg

Intervention Type: BIOLOGICAL

single-dose:10mg/kg

GB226 1mg/kg multiple dosing, every 2 weeks

Geptanolimab, 1mg/kg, i.v., q2w\*6

Group Type: EXPERIMENTAL

Geptanolimab Injection 1mg/kg, q2w*6

Intervention Type: BIOLOGICAL

multiple dosing: 1mg/kg, q2w\*6

GB226 3mg/kg multiple dosing,every 2 weeks

Geptanolimab, 3mg/kg, i.v., q2w\*6

Group Type: EXPERIMENTAL

Geptanolimab Injection 3mg/kg, q2w*6

Intervention Type: BIOLOGICAL

multiple dosing: 3mg/kg, q2w\*6

GB226 10mg/kg multiple dosing, every 2 weeks

Geptanolimab,10mg/kg, i.v., q2w\*6

Group Type: EXPERIMENTAL

Geptanolimab Injection 10mg/kg, , q2w*6

Intervention Type: BIOLOGICAL

multiple dosing: 10mg/kg, , q2w\*6

GB226 280mg multiple dosing

Geptanolimab, 280mg, i.v., q3w

Group Type: EXPERIMENTAL

Geptanolimab Injection 280mg, q3w

Intervention Type: BIOLOGICAL

multiple dosing: 280mg, q3w

GB226 3mg/kg multiple dosing

Geptanolimab, 3mg/kg, i.v., q2w

Group Type: EXPERIMENTAL

Geptanolimab Injection 3mg/kg, q2w

Intervention Type: BIOLOGICAL

multiple dosing: 3mg/kg, q2w

Interventions

Geptanolimab Injection 1mg/kg

single-dose:1mg/kg

Intervention Type: BIOLOGICAL

Geptanolimab Injection 3mg/kg

single-dose: 3mg/kg

Intervention Type: BIOLOGICAL

Geptanolimab Injection 10mg/kg

single-dose:10mg/kg

Intervention Type: BIOLOGICAL

Geptanolimab Injection 1mg/kg, q2w*6

multiple dosing: 1mg/kg, q2w\*6

Intervention Type: BIOLOGICAL

Geptanolimab Injection 3mg/kg, q2w*6

multiple dosing: 3mg/kg, q2w\*6

Intervention Type: BIOLOGICAL

Geptanolimab Injection 10mg/kg, , q2w*6

multiple dosing: 10mg/kg, , q2w\*6

Intervention Type: BIOLOGICAL

Geptanolimab Injection 280mg, q3w

multiple dosing: 280mg, q3w

Intervention Type: BIOLOGICAL

Geptanolimab Injection 3mg/kg, q2w

multiple dosing: 3mg/kg, q2w

Intervention Type: BIOLOGICAL

Other Intervention Names

Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection; Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection; Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection; Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection; Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection; Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection; Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection; Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genor Biopharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuankai Shi, Doctor

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: NOT_YET_RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shawn Yu, Master

Role: CONTACT

shawn.yu@genorbio.com

86-010-65260820

Facility Contacts

Yuankai Shi, Doctor

Role: primary

Qingyuan Zhang, Doctor

Role: primary

Other Identifiers

Gxplore-001

Identifier Type: -

Identifier Source: org_study_id