To explore the tolerability and pharmacokinetics of TQB2101 for injection in subjects with advanced malignant tumors.
The subjects voluntarily joined the study, signed the informed consent, and had good compliance;
18 years old ≤ age ≤75 years old (calculated on the date of signing the informed consent);
Eastern Cooperative Oncology Group (ECOG) score 0~1;
Expected survival greater than 12 weeks;
Had or was currently suffering from other malignant tumors within 3 years prior to the first medication.
There are multiple factors that affect intravenous injection, venous blood collection diseases, or have an impact on oral drugs.
The adverse reactions of previous treatment failed to recover to Common Terminology Criteria for Adverse Events Version 5 (CTCAEv5.0) score ≤1.
Patients who had major surgical treatment, significant traumatic injury, or potential major surgery during the expected study treatment period within 4 weeks prior to initial medication, or who had long-term unhealed wounds or fractures.
Single group
TQB2101 for injection
DrugTQB2101 for injection is a receptor tyrosine kinase-like orphan receptor-1 antibody drug conjugate.
Phase II recommended doses (RP2D)
The dosage of drug therapy recommended for use in the second phase of clinical trials (i.e., phase II clinical trials).
Dose-limiting toxicity (DLT)
Adverse events that meet the protocol definition of dose-limiting toxic event timing were evaluated according to the Common Terminology Criteria for Adverse Events 5.0.
Maximum tolerated dose (MTD)
The previous dose of the dose group in which dose-limiting toxicity occurs is the maximum tolerated dose.
Incidence and severity of adverse event (AE) and serious adverse event (SAE), and abnormal laboratory test indicators
Incidence and severity of AE and SAE, and abnormal laboratory test indicators
Peak time
Time to peak blood concentration after a single dose.
Peak concentration Cmax
After a single dose, the highest point of the drug-time curve is called the peak concentration.
Plasma elimination half-life t1/2
The amount of time it takes for the concentration of the drug in the blood, or the amount of drug in the body, to drop to about half of its original level.
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