TQB6411 for injection is an antibody-conjugated drug (ADC) targeting EGFR/c-Met. After injecting blood intravenously, the antibody part of this product binds to the surface of EGFR and c-Met on tumor cells to block the activation of EGFR and c-Met signaling pathways. The ADC is enzymatically transported to the lysosome. The linker releases toxins after enzyme cleavage, resulting in DNA damage and cell death. TQB6411 for injection is intended for the treatment of advanced malignant tumors.
The subjects voluntarily joined the study, signed an informed consent form, and had good compliance;
18 years old≤age age≤75 years old (calculated based on the date of signing the informed consent form);
Eastern Cooperative Oncology Group (ECOG) score 0~1 point;
Expected survival is greater than 12 weeks;
Have appeared or are currently suffering from other malignant tumors;
There are diseases that affect intravenous injection and intravenous blood collection;
The adverse reactions of previous treatments failed to recover to CTCAE V5.0 grade score ≤1, except for toxicity without safety risk, such as grade 2 hair loss, grade 2 peripheral nerve toxicity, grade 2 anemia, non-clinical significance and asymptomatic grade 2 laboratory abnormalities, stable hypothyroidism with hormone replacement therapy;
Those who have received major surgical treatment, obvious traumatic injury or major surgery during the expected study treatment within 4 weeks before the first medication (except for the surgery stipulated in the program), or have long-term uncured wounds or fractures;
Single group
TQB6411 injection
DrugTQB6411 for injection is an antibody-conjugated drug (ADC) targeting EGFR/c-Met. After injecting intravenously, the antibody part of this product binds to the EGFR and c-Met on the surface of tumor cells to block the activation of EGFR and c-Met signaling pathways. The ADC is enrolled and transported to the lysosome through cells. The linker releases toxins after enzyme cleavage, resulting in DNA damage and cell death.
Dose-limiting toxicity
Dosage-limiting toxicity refers to any of the following events that researchers and sponsors believe to be related to the treatment of TQB6411 for injection (including positively related, likely related, and possible related) (except for special instructions, the degree of adverse events is evaluated in accordance with National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events (AE) v5.0.
Maximum Tolerated Dose
Defined as the highest dose in less than 33% of subjects with dose-limiting toxicity (DLT).
Phase II recommended dose
The recommended dose for subsequent phase II studies will be determined based on Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), preliminary efficacy and safety.
Rate and severity of adverse events
Rate and severity of adverse events
Peak drug concentration (Cmax)
It refers to the highest blood drug concentration achieved after administration of TQB6411 for injection.
Area under the concentration-time curve from time zero to the last measurable concentration time t (AUC0-t)
Area under the concentration-time curve from time zero to the last measurable concentration time t (AUC0-t).
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞).
Peak time (Tmax)
It refers to the time when the maximum blood drug concentration is reached after administration of TQB6411 for injection.
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