China patients with advanced and/or relapsed solid tumor/lymphoma
Conditions
Interventions
Arm 1:Single administration of GB226
Arm 2:Multiple administration of GB226
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years male and femal; 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, NK-T cell lymphoma and mediastinal B cell lymphoma) conformed by histology or cytology and cannot be cured by surgery. Currently lack of effective standard treatment; 4. Agree to provide recorded tumor tissue sample or fresh tissue sample; 5. ECOG0-1; 6. Expected life = 3 months; 7. With at least one measurable and evaluable tumor (solid tumor is subject to criteria for evaluating efficacy of immunotherapy 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 protopathy. For patients of solid tumor, hemoglobin=9g/dl, neutrophile granulocyte=1.5×10^9/L, blood platelet=100×10^12/L. For patients of hematologic tumor, hemoglobin=8g/dl, neutrophile granulocyte=1.0×10^9/L, blood platelet=80×1012/L. 15. Serum creatinine=1.5xULN 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; 16. For patients without liver metastasis, total bilirubin<1.5xULN, aspartate transaminase (AST) and alanine aminotransferase (ALT)<2.5xULN. For patients with liver metastasis/liver cancer, total bilirubin 3xULN, transaminase<5xULN; 17. Functional parameter of thyroid: thyrotropic hormone (TSH) and free thyroxine (FT3/FT4) in normal range; 18. Adverse effect caused by previous treatment shall recover to less than level 1 (excluding alopecia); 19. Pregnancy tests of women patients in reproductive period are negative. Men or women all agree to adopt effective contraception measures medically during the trial and within 6 months after the trial; 20. Patients may be visited regularly and can execute good communication with researchers. Besides, they can complete the research according to regulations of the research.
Exclusion criteria
Exclusion criteria: 1. Active central nervous system metastasis; If 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 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; 11. With usage of other research drugs 30 days before or within 5 half-life periods of other research drugs (subject to the longer); or with usage of research devices within 30 days; 12. With anti-infection vaccine (eg. influenza vaccine, varicella vaccine) 4 weeks before the inclusion; 13. With symptomatic seroperitoneum or pleural effusion; 14. With the history of drug abuse or alcohol addiction; 15. With interstitial lung disease at present or in the past; 16. Breast feeding women; 17. With treatment of other trial drugs or participation in other clinical trial within 30 days before the inclusion; 18. Allergic to recombinant humanized monoclonal antibody or any other ingredients; 19. With other nervous or metabolic dysfunction; with contraindicant research drugs in the results of physical examination or laboratory examination; or with risks of suspected diseases or symptoms of complications related to the treatment; 20. Women not taking effective related complications during the research or within 6 months after last usage of Genolimzumab Injection; men disagreeing to take effective related complications during the research or within 90 days after last usage of Genolimzumab Injection; 21. Patients with insufficient communication, understanding or cooperation; or patients not following the scheme with poor compliance; 22. Those not fitting the clinical trial due to various reasons from the viewpoints of the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8;Tmax;Vd;t1/2;CL;Ke; | — |
Countries
China
Contacts
Public ContactFiona Cheng
Genor Biopharma Co. Ltd.
Outcome results
None listed