clinical trial of tqb2868 injection in subjects with advanced malignant tumors

Conditions: Advanced Malignant Tumor

Summary: the tqb2868 protein in this study targeted programmed cell death protein 1 (pd-1) and transforming growth factor-β (tgf-β). the bifunctional fusion protein targets and neutralizes tgf-β in the tumor microenvironment. on the basis of inhibiting pd-1 / programmed death ligand 1 (pd-l1) pathway, t cells can restore activity, enhance immune response, and more effectively improve the effect of inhibiting tumor occurrence and development.


Eligibility criteria:
inclusion criteria: * 1 subjects voluntarily join the study and sign an informed consent form. * 2 age: 18-75 years old (when signing the informed consent form); eastern cooperative oncology group performance status (ecog ps) score: 0\~1 points. * 3 advanced malignant tumors clearly diagnosed by histology or cytology. * 4 patients with advanced malignant tumors who have been diagnosed by tissue and/or cytology and have failed standard treatments or lack effective treatment options. * 5 the main organs are in good function, and the following examination results are good: routine blood examination, biochemical examination, blood coagulation function examination, heart color doppler ultrasound evaluation. * 6 female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study; serum pregnancy/urine within 7 days before study entry the pregnancy test is negative and must be a non-lactating subject; male subjects should agree that contraception must be used during the study period and within 6 months after the end of the study period. exclusion criteria: * 1 combined diseases and medical history: 1. has had other malignant tumors within 3 years before the first medication. the following two conditions can be included in the group: other malignant tumors treated with a single operation to achieve disease-free survival (dfs) for 5 consecutive years; cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[ ta (non-invasive tumor), tis (carcinoma in situ) and t1 (tumor infiltrating basement membrane)\]; 2. unrelieved toxic reactions higher than common terminology criteria adverse events (ctc ae) level 1 or higher caused by any previous treatment, excluding hair loss; 3. major surgical treatment, obvious traumatic injury or long-term unhealed wounds or fractures have been received within 28 days before the first medication; 4. arterial/venous thrombosis occurred within 6 months before the first administration, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 5. existence of active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment or active pneumonia with clinical symptoms; 6. people who have a history of psychotropic drug abuse and cannot be quit or have mental disorders; 7. previous recipients of allogeneic bone marrow transplantation or solid organ transplantation. 8. subjects with any severe and / or uncontrolled disease. * 2 tumor-related symptoms and treatment: 1. have received chemotherapy, radiotherapy or other anti-cancer therapies within 4 weeks before the first medication (the washout period will be calculated from the end of the last treatment); if you have received local radiotherapy in the past, you can join the group if the following conditions are met: end of radiotherapy more than 4 weeks from the start of the study treatment (brain radiotherapy is more than 2 weeks); and the target lesion selected for this study is not in the radiotherapy area; or the target lesion is located in the radiotherapy area, but progress has been confirmed. 2. received chinese patent medicine treatment with anti-tumor indications specified in the national medical products administration (nmpa) approved drug instructions within 2 weeks before the first medication; 3. have previously received immunological double-antibody therapeutic drugs against the same target of tqb2868 injection; 4. uncontrollable pleural effusion, pericardial effusion or ascites that still needs to be drained repeatedly (investigator's judgment); 5. known to have spinal cord compression, cancerous meningitis, accompanied by brain metastasis symptoms, or symptom control time less than 2 weeks; * 3 research and treatment related: 1. the history of live attenuated vaccine vaccination within 28 days before the first administration or the planned live attenuated vaccine vaccination during the research period; 2. those who have had severe hypersensitivity reactions after using macromolecular drugs; 3. an active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, corticosteroids, or immunosuppressive agents) occurred within 2 years before the first medication. alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments; 4. diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose\>10mg/day prednisone or other curative hormones), and continue within 2 weeks of the first administration in use; * 4 participated in other anti-tumor drug clinical trials within 4 weeks before the first medication; * 5 according to the judgment of the researcher, there are situations that seriously endanger the safety of the subjects or affect the completion of the research by the subjects.