Clinical Trial of TQB3205 Capsule in Subjects With Advanced Malignant Tumors

Phase I Clinical Trial to Evaluate the Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3205 Capsule in Subjects With Advanced Malignant Tumors

The trial was divided into two phases: dose escalation and dose expansion. The dosing regimens were single-dose study and continuous dosing study. A single-center, open, non-randomized, single-arm clinical trial design was adopted. Subjects with advanced malignant tumors were selected to take TQB3205 capsules orally to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TQB3205 capsules.

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.