Solid Tumors
Conditions
Interventions
Single arm:Recombinant Humanized Anti-PD-1 Monoclonal Antibody Solution for Injection
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The informed consent was signed before the trial, fully understood the content and process of the trial and the possible adverse reactions. 2. Be able to complete the study according to the protocol. 3. Expected survival over 5 months. 4. Male and female patients aged 18-70 years old (including 18 and 70 years old). 5. Standard treatment failure or intolerance standard treatment or top, and unconditional acceptance standard treatment, and the histology and cytology diagnosis of advanced or metastatic solid tumor(Priority non-small cell lung cancer,melanoma, head and neck cancer, renal carcinoma,bladder cancer and microsatellite was highly unstable MSI-H or mismatched to repair defect dMMR with all solid tumors; 6. According to RECIST 1.1, there was at least one measurable target lesion; 7. ECOG P.S score (see appendix 3) was 0 or 1. 8. Laboratory marker: Neutrophil count was 1. 5 x 10^9 /L (no medically required intervention two weeks before screening); Platelet count was 75x 10^9/L; Hemoglobin 90g/L (No blood transfusion was required 2 weeks before screening); Prothrombin time (PT) or international standardized ratio (INR) and partial thrombin time (APTT) was 1.5 ULN; Total bilirubin (TBil) was 1.5xULN;or Total bilirubin(TBil) 1.5 ULN (direct bilirubin ULN); No liver metastasis: Aspartate aminotransferase (AST) was 3 ULN; Alanine aminotransferase (ALT) was 3 ULN; Liver metastasis: Aspartate aminotransferase(AST) was 5xULN; Alanine aminotransferase(ALT) was 5xULN;Alkaline phosphatase (ALP) was 5xULN; Serum creatinine 1.5 ULN; Serum creatinine clearance>50ml/min(by Cockcroft-Gault, see appendix 4); 9. Normal or abnormal thyroid function has no clinical significance (patients with hypothyroidism who return to normal level or abnormal due to treatment have no clinical significance can be included); 10. Patients with fertility of women (please see appendix 9) definition, must be made within 7 days before the delivery for the first time the serum pregnancy test negative and willing to during the study until the last six months after the treatment to adopt effective birth control/male contraception to prevent pregnancy patients must be agreed to during the study period until the last six months after the treatment, to take effective contraceptive methods.
Exclusion criteria
Exclusion criteria: 1. Participating in or participating in a clinical study of an experimental drug or medical device within 4 weeks of first treatment; 2. Patients had a history of other malignancies in the 5 years before they were first treatment, except for basal cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ or other cancers in situ; 3. Patients with known active central nervous system(CNS) metastatic carcinoma and/or cancerous meningitis. A history of brain metastasis is not excluded if the patient is stable at least 4 weeks before the first treatment, there is no evidence of new or expanded brain metastasis, and steroid therapy is discontinued at least 7 days before the first treatment; 4. Previously received anti-PD-1 anti-PD-L1 or anti-CTLA-4 inhibitors; 5. Had been treated with chemotherapy, radiotherapy or biologics within 4 weeks of first treatment; Or have been treated with tyrosine kinase inhibitors for five half-lives, as follows, but not limited to: Patients who did not return to CTCAE level 1 after 4 weeks of anti-tumor therapy, except hair loss; 6. Any other form of antitumor therapy is being accepted or anticipated during the study period; 7. Patients with symptomatic autoimmune diseases (e.g., but not limited to: interstitial pneumonia,uveitis, enteritis, hepatitis, pituitary hypophysitis,vasculitis,nephritis,hyperthyroidism,hypothyroidism;Subjects with vitiligo or asthma in childhood were in complete remission and could be included in adulthood without any intervention. Subjects who needed bronchodilators for medical intervention were excluded from asthma.) 8.Need long-term systemic sex hormone therapy or body or absorb local hormone treatment of immunosuppression in order to achieve the purpose of application of physiological doses of hydrocortisone acetate replacement therapy, or other quite dose hormone of patients can into groups: a daily dose of 30 mg hydrocortisone acetate or 7.5 mg prednisone, among them early in the morning to take 20 mg hydrocortisone acetate (or 5 mg prednisone), after breakfast to take 10 mg hydrocortisone acetate (or 2.5 mg prednisone); 9. Interstitial lung disease, or treated pneumonia; 10. There are clinically significant active infections that require systemic treatment; 11. There is human immunodeficiency virus (HIV) infection or syphilis infection; 12. It indicates a latent or definite active pulmonary infection; 13. HCV-Ab positive or HBsAg positive (if HBsAg negative, HBcAb positive and HBsAb negative, hbv-dna should be determined, and the upper limit of DNA superwindow normal detection should be excluded); 14. There is a risk of intestinal obstruction or perforation; 15. Had been vaccinated or planned to be vaccinated with live/attenuated vaccine within 4 weeks prior to screening; 16. Severe hypersensitivity to any monoclonal antibody is known to occur; 17. Patients who are known to have a history of psychiatric drug abuse or drug use and are considered to have an impact on compliance in this study; 18. Pregnant or nursing women; 19. The investigator considers that the patient is not fit to participate in the study (for example, failure to understand and/or comply with the study requirements, or the investigator believes that other conditions of the patient will result in unsafe participation in the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Security;Pharmacokinetics;Immunogenicity; | — |
Countries
China
Contacts
Public ContactDing Yanhua
The First Hospital of Jilin University
Outcome results
None listed