Phase I clinical trial to explore the safety, tolerability, and initial efficacy of TQB3911 tablets in BCR::ABL fusion gene positive leukemia.
The subjects voluntarily joined the study, signed the informed consent, and had good compliance;
Age: ≥18 years old (when signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-2; Expected survival of more than 3 months;
During the screening period, the patients were identified as Chronic myelogenous leukemia-Chronic phase (CML-CP) or accelerated phase (AP) patients by bone marrow cell morphological examination, molecular biological examination or cytogenetic examination;
Chronic myelogenous leukemia (CML) patients who are intolerant to Tyrosine kinase inhibitors (TKI) drugs or whose therapeutic effect is not satisfactory (that is, the therapeutic response evaluation result is failure)
Had or was currently suffering from other malignant tumors within 5 years before the first medication
Combined with active central nervous system leukemia
Major surgical treatment and significant traumatic injury were received within 28 days before the start of study treatment
Previous history of myocardial infarction, pulmonary hypertension, or angina pectoris within 3 months before the first medication, or clinically significant arrhythmias such as ventricular tachycardia, complete left bundle branch block, and high atrioventricular block
Single group
TQB3911 tablets
DrugTQB3911 is a small molecule BCR::ABL1 allosteric inhibitor. By occupying the myristyl binding site, TQB3911 recovers the inhibition of BCR::ABL1 fusion protein kinase activity, and ultimately inhibits the proliferation of tumor cells.
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.
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
C-QT Research
Effect of TQB3911 on QTcF interval in subjects
Platelet count
Hematologic remission of subjects during treatment
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