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.
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.
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;