a study to evaluate the tolerance and pharmacokinetics of tqb2858 injection in subjects with terminal malignant tumors

Conditions: Terminal Malignant Tumors

Summary: this study is a phase i study to evaluate the safety and tolerability of tqb2858 injection in patients with advanced malignancy.


Eligibility criteria:
inclusion criteria: * patients with advanced malignancies diagnosed histologically and/or cytologically, where standard treatment has failed or there is no effective treatment; * age: 18-75 years old; * ecog score: 0 \~ 1; * expected survival of more than 3 months; * the main organs are functioning normally; * women of childbearing age must be negative for serum or urine hcg within 7 days prior to study enrollment and must be non-lactating;patients should agree to use contraception during the study period and for 6 months after the study period. * patients voluntarily joined the study and signed the informed consent, showing good compliance. exclusion criteria: -complicated disease and history: a) has developed other malignant tumors within 2 years or is currently suffering from the same tumor; b) unmitigated toxic reactions above ctc ae grade 1 due to any prior treatment, excluding hair loss and peripheral sensory nerve disorders; c) received major surgical treatment or significant traumatic injury (excluding needle biopsy) within 28 days prior to the commencement of study treatment; d) long-term unhealed wounds or fractures; e) the occurrence of arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; f) people with a history of psychotropic substance abuse and inability to quit or with mental disorders; g) subjects with any severe and/or uncontrolled disease;" -tumor-related symptoms and treatment: a) had undergone surgery, chemotherapy, radiation or other anticancer therapy within 4 weeks prior to the start of study treatment (washout period was calculated from the end of the last treatment); b) chinese patent drugs with anti-tumor indications specified in the nmpa approved drug specifications (including compound cantharide capsule, kangai injection, kanglaite capsule/injection, aidi injection, brucea oil injection/capsule, xiaoaoping tablet/injection, huabenin capsule, etc.) were received within 2 weeks before the start of the study; c) previously received immunodouble antibody therapy targeting the same target of tqb2858 injection; d) uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (as determined by the investigator); e) patients with brain metastases whose symptoms stabilized less than 4 weeks after discontinuation of dehydrants and steroids;" -research treatment related: a) a history of live attenuated vaccine vaccination within 28 days prior to the study treatment initiation or a planned live attenuated vaccine vaccination during the study period; b) previous history of severe allergy to macromolecular drugs or known components of tqb2858 injection; c) study the occurrence of active autoimmune disease requiring systemic treatment (e.g., use of palliative drugs, corticosteroids, or immunosuppressants) within 2 years prior to treatment initiation.alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic; d) have been diagnosed with immunodeficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy.(dose of \>10mg/ day prednisone or other equivalent efficacy hormone), and continued to use within 2 weeks of the first administration;" participants had participated in other antitumor drug clinical trials in the previous 4 weeks; -subject who, in the investigator's judgment, has a concomitant disease that seriously endangers the subject's safety or affects the completion of the study, or is considered unsuitable for inclusion for other reasons.