Advanced Solid Tumors
Conditions
Interventions
case series:None
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects or legal representatives need to fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer as participants, and sign an informed consent form before any procedure begins. 2. Aged 18 years (including the critical value) and above, and the gender is not limited. 3. Expected survival time >= 3 months. 4. Locally advanced or metastatic solid tumors diagnosed by histopathology or cytology, and the standard treatment has failed, or there is no standard treatment plan, or the current stage is not suitable for standard treatment. 5. At least one measurable lesion during the screening period according to RECIST v1.1 criteria. 6. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. 7. The organ function of the subject meets the following criteria: (1) Bone marrow reserve is basically normal: hemoglobin >=9g/dL, absolute neutrophil count (ANC) >=1.5x10^9/L, platelets >=75x10^9/L; (2) The liver function is basically normal: bilirubin=50mL/min; (4) The coagulation function is basically normal: the international normalized ratio (INR) is less than or equal to 1.5, and the activated partial thromboplastin time (APTT) is less than or equal to 1.5xULN; (5) Cardiac function: Left ventricular ejection fraction (LVEF) >= 50%; QT interval (QTcF) <= 470 ms for women and <= 450 ms for men; (6) Endocrine system: Thyroid-stimulating hormone (TSH) is within the normal range. 8. Subjects with childbearing potential must agree to take medically recognized effective contraceptive measures throughout the trial period and at least 3 months after the last dose; Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose.
Exclusion criteria
Exclusion criteria: 1. Chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anticancer therapy within 4 weeks. 2. Concurrent medical condition requiring the use of other systemic immunosuppressive treatment within 4 weeks before the first dose of study treatment. 3. Receipt of any live vaccine within 4 weeks of the start of study treatment. 4. Receipt of unmarketed clinical trial drugs or treatments within 4 weeks of the start of study treatment. 5. Receipt of surgery or interventional treatment (excluding tumor biopsy, puncture, etc.) within 4 weeks of the start of study treatment. 6. History or evidence of cardiovascular and cerebrovascular diseases risk. 7. Subjects with uncontrolled diabetes. 8. Symptomatic central nervous system (CNS) metastases or asymptomatic CNS metastases that have required steroids within 2 weeks prior to first dose of study treatment. 9. The imaging examination showed that there was a clear tumor invading the great blood vessels of the chest. 10. Currently or in the past suffering from malignant tumors. 11. Uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently after appropriate intervention. 12. Active or suspected autoimmune disease. 13. History of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis. 14. Toxicity from previous treatment including: Toxicity Grade >=3 related to prior immunotherapy and that led to study treatment discontinuation; Toxicity related to prior treatment that has not resolved to Grade <= 1. 15. Subjects who have acute bacterial, viral or fungal infections and require systemic anti-infective treatment. 16. Positive test for syphilis antibodies or human immunodeficiency virus (HIV) antibodies. 17. Subjects who are allergic to test drugs and excipients. 18. Subjects who are breastfeeding. 19. Known drug or alcohol abuse. 20. Subjects with mental or neurological diseases. 21. Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation. 22. Subjects who have a history of serious systemic disease or any other reason are not suitable to participate in this trial as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event;Severe Adverse Event;Dose-Limiting Toxicity;Maximum Tolerated Dose;Phase II Recommended Dosage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma Concentration - Area Under the Time Line;Peak Concentration;Peak Time; | — |
Countries
China
Contacts
Public ContactHu Ying
Affiliated Beijing Chest Hospital of Capital Medical University
Outcome results
None listed