Phase I clinical trial to explore the safety, tolerability, and initial efficacy of TQB3911 tablets in BCR::ABL fusion gene positive leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
TQB3911 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.
Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
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).
Time frame: Baseline up to 24 months
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.
Time frame: Up to 1 month
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
Time frame: From the signing of informed consent for administration to 28 days after the last administration/start of the new antitumor therapy (whichever occurs first).
Peak time
Time to peak blood concentration after a single dose
Time frame: Single dose on days 1 to 3, day 8 of cycle 1, day 15 of cycle 1, day 22 of cycle 1, and day 2 to day 1, each cycle is 28 days.
C-QT Research
Effect of TQB3911 on QTcF interval in subjects
Time frame: Single dose: 1 hour, 0.5 hour, 10 minutes before dose and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours after dose.
Platelet count
Hematologic remission of subjects during treatment
Time frame: For the first six weeks, the assessment was weekly. Starting at week 6, assessments were performed at week 8 and every 4 weeks (±7 days) thereafter
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The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The proportion of Philadelphia chromosomes in the metaphase of bone marrow cells
Cytogenetic remission of subjects during treatment
Time frame: They were evaluated every 12 weeks (±7 days) for 96 weeks and every 24 weeks (±7 days) after 96 weeks
Molecular reaction
Molecular remission of subjects during treatment
Time frame: They were evaluated every 12 weeks (±7 days) for 96 weeks and every 24 weeks (±7 days) after 96 weeks
Progression free survival
The period of time between the subject's treatment and the observation of disease progression or death from any cause
Time frame: They were evaluated every 12 weeks (±7 days) for 96 weeks and every 24 weeks (±7 days) after 96 weeks
Overall survival
The time from the subject's initiation of treatment or diagnosis until the patient's death from any cause
Time frame: They were evaluated every 12 weeks (±7 days) for 96 weeks and every 24 weeks (±7 days) after 96 weeks
Peak concentration Cmax
After a single dose, the highest point of the drug-time curve is called the peak concentration
Time frame: Single dose on days 1 to 3, day 8 of cycle 1, day 15 of cycle 1, day 22 of cycle 1, and day 2 to day 1, each cycle is 28 days.
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.
Time frame: Single dose on days 1 to 3, day 8 of cycle 1, day 15 of cycle 1, day 22 of cycle 1, and day 2 to day 1, each cycle is 28 days.