Clinical Trial of TQB3205 Capsule in Subjects With Advanced Malignant Tumors

Inclusion criteria

• Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
• ≥18 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-1; at least 3 months expected survival period.
• At least 1 measurable lesion for efficacy evaluation.
• The function of main organs is normal.
• Women of childbearing age should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study, and have a negative serum or urine pregnancy test within 7 days before enrollment in the study; Men should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study period.

Exclusion criteria

• Individuals who have undergone major surgical treatment, significant traumatic injury, or major surgery during the expected study treatment period within 4 weeks prior to the first medication (excluding surgeries specified in the protocol), or have long-term untreated wounds or fractures. (Major surgery is defined as surgery at level 3 or above in the National Surgical Classification Catalogue 2022 edition);
• Subjects who experience any bleeding or bleeding events ≥ CTC AE grade 3 within 4 weeks prior to the first administration.
• Active syphilis infected individuals in need of treatment
• Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
• Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation;
• History of hepatic encephalopathy;
• Active or uncontrolled infections (≥ CTC AE level 2 infection);
• 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;
• Poor control of diabetes (assessed by the investigator);
• Known to be allergic to research drugs or excipients;
• Those who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first medication;
• According to the researcher's judgment, there is a situation that seriously endangers the safety of the subjects or affects their ability to complete the study.