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;
Single group
TQB3205 capsules
DrugTQB3205 capsule is a targeted protein degrader
Dose Limiting Toxicity (DLT)
DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI Common Terminology Criteria for Adverse Events(CTCAE) version6.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred from first medication to the end of the first treatment cycle.
Maximum tolerated dose (MTD)
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Recommended Phase II Dose (RP2D)
RP2D describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3205 capsules in adult patients with Advanced Malignant Cancer
Maximum assessed dose (MAD)
Recommendations made by the investigator and sponsor based on clinical safety, efficacy, Pharmacokinetics (PK), and Pharmacodynamics (PD) data will be considered the highest dose level to complete dose exploration in the absence of an Maximum Tolerated Dose (MTD).
Overall response rate (ORR)
The proportion of subjects with best response of Complete response, partial response, Very good partial response, and Minimal response.
Tmax
Time to Reach the Maximum Plasma Concentration
Cmax
Cmax is the maximum plasma concentration of TQB3205.
Elimination half-life (t1/2)
To evaluate the elimination half-life (t1/2) after oral dose of TQB3205 capsules to subjects.
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