a multicenter, open label phase i clinical trial evaluating the safety and pharmacokinetics of tqb2252 injection in subjects with advanced malignant tumors

Conditions: Advanced Cancers

Summary: this study is a multicenter, single arm, and open design phase i clinical trial aimed at evaluating the safety, pharmacokinetics (pk) characteristics, immunogenicity, and preliminary efficacy of tqb2252 injection in subjects with advanced malignant tumors.


Eligibility criteria:
inclusion criteria: * the subjects voluntarily joined this study, signed an informed consent form, and showed good compliance; * 18 years old ≤ 75 years old (calculated from the date of signing the informed consent form); * electrocorticogram (ecog) score ranges from 0 to 1 points; * expected survival is greater than 12 weeks； * confirmed to have at least one measurable lesion according to recist 1.1 (solid tumor) or lugano 2014 (lymphoma) criteria； * late stage malignant tumor subjects who have failed standard treatment or lack effective treatment； * women of childbearing age should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study; men should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study period. exclusion criteria: * has experienced or currently has other malignant tumors within the past 5 years prior to the first use of medication; * there are multiple factors that affect diseases related to intravenous injection and venous blood collection; * the adverse reactions of previous anti-tumor treatments have not recovered to a common terminology criteria for adverse events (ctcae) v5.0 score of ≤ 1; * individuals who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication; * subjects who experience any bleeding or bleeding events ≥ ctcae grade 3 within 4 weeks prior to the first administration; * an arterial/venous thrombotic event occurred within 6 months prior to the first administration; * active viral hepatitis with poor control; * active syphilis infected individuals in need of treatment; * history of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or clinically symptomatic active pneumonia; * individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; * diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy due to a history of hepatic encephalopathy; * previously experienced grade 3 or higher adverse reactions related to immunotherapy; * suffering from significant cardiovascular disease; * active or uncontrolled severe infections; * patients with renal failure requiring hemodialysis or peritoneal dialysis; * history of immunodeficiency, including hiv positivity or other acquired or congenital immunodeficiency diseases; * individuals with epilepsy who require treatment; * previously received treatment with similar anti-lag3 drugs.