Tumor
Conditions
Interventions
chort:GLS-010
Sponsors
Beijing Cancer Hosptical
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects meet the following corresponding requirements for the stage of the study they will enroll into: 1. Subjects have voluntarily agreed to participate in the study; Fully understand and know the study and sign the informed consent; Willing to follow and be able to complete all procedures; 2. Male or female, and aged 18 to 75 years (including 18 and 75 years); 3. Subjects must have an imaging and histologically or cytologically confirmed advanced solid tumor; Dose escalation study: Subjects with advanced solid tumor (mainly gastric cancer, esophageal cancer) Expansion study: Patients with gastric cancer and esophageal cancer are expected to be enrolled which determine by the results of the dose escalation study; 4. Subjects must have archival tumor tissues or agree to a tumor biopsy during screening period. 5. Subjects have no standard effective treatment or are ineffective with standard treatment. 6. Subjects must have at least one measurable lesion as defined per RECIST Version 1.1. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 8. Life expectancy =12 weeks; 9. Subject must have adequate organ function and hematopoietic function indicated by the following laboratory values: Hemoglobin (HGB)=90 g/L; White blood cell count (WBC)=3×10^9/L; Absolute neutrophil count (ANC) =1.5×10^9/L; Platelets =100×10^9/L; Serum total bilirubin (TBIL) = 1.5 *upper limit of normal ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=2.5 X ULN OR =5 X ULN for subjects with liver metastases; Serum creatinine =1.5*ULN; International Normalized Ratio (INR) or Prothrombin Time (PT) =1.5*ULN. 10. Childbearing potential female subjects or male subjects must agree to use adequate contraception after signing informed consent, and throughout the study until 5 months after the last GLS-010 administration.
Exclusion criteria
Exclusion criteria: Subjects meet any of the following corresponding requirements for the stage of the study they will not enroll into: 1. Patients with meningeal or symptomatic central nervous system metastases; 2. Subjects with symptomatic autoimmune diseases(including but not limited to interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism[except for hypothyroidism caused by radiotherapy], Subjects with vitiligo or asthma in childhood had been completely relieved, and no intervention was required when they grow to manhood can be enrolled in, subjects who needed bronchial dilation for medical intervention were not enrolled in); 3. Subjects who require systemic corticosteroids (at doses equivalent to or greater than 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to or during the study; 4. Subjects who have received anti-tumor vaccine or who have received anti-tumor drug treatment with immune-stimulating effect within 4 weeks before screening; 5. Subjects who have been treated with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody or anti-lymphocyte antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically acting on a T cell co-stimulatory or checkpoint pathway); 6. In addition to treated cervical carcinoma in situ and recovered skin basal cell carcinoma, other malignant tumors developed within 5 years prior to administration; 7. Subjects with positive HBsAg and HBV DNA>103 copies /mLor subjects with positive hepatitis C antibody; subjects with positive syphilis; 8. Subjects with a history of infection with human immunodeficiency virus, or other acquired, congenital immunodeficiency disease, or organ transplantation; 9. Subjects with active tuberculosis infection or active tuberculosis infection within 1 year prior to administration, or subjects with active tuberculosis infection more than 1 year prior to administration without formal treatment; 10. Subjects with active infection or unexplained fever >38.5? during screening and prior to first administration (subject with fever caused by tumor may be included in the group as determined by the investigator); 11. Known subjects who have previously been allergic to macromolecular protein formulations/monoclonal antibodies or to any of the pharmaceutical ingredients tested; 12. Subjects having participated in clinical trials of other drugs within 4 weeks before administration; 13. Subjects who received chemotherapy, radiotherapy, molecular targeted therapy or large-scale surgical treatment within 2 weeks before administration; Clinically significant AEs associated with previous treatment have not restored to baseline or =1 (except for alopecia); 14. Subjects who have failed to control the clinical symptoms or diseases of the heart, such as uncontrolled hypertension, unstable angina pectoris or subjects who have myocardial infarction within 6 months before administration, or subjects who have poor control of arrhythmia ( including QTc interval male =450 ms, women =470 ms, QTc interval calculated by Fridericia formula), etc.; 15. Subjects who have history of interstitial lung disease or non-infectious pneumonia (other than those caused by radiotherapy). 16. Subjects who have a history of alcoholism, drug abuse or drug abuse in the past 1 year; 17. Subjects who have a clear history of neurological or psychiatric disorders, such as
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerance;Preliminary antitumor effect; | — |
Countries
China
Contacts
Public ContactLi Guochun
Outcome results
None listed