This is a open-label, dose escalation, accelerated titration combined 3+3 design, phase I study, to evaluate the safety and tolerability, and to determine the RP2D of TR64 when administered qd in patients with advanced solid tumors. Up to 6 cohorts of 1-6 or 3-6 patients each will be treated in the study.
Patients will receive study treatment until criteria for study termination are met. A Safety Follow-up Visit will be conducted 28 days (±7 days) after the last dose of study treatment. Patients who discontinue study treatment for reasons other disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient withdraws consent, is lost to follow-up, death, or until the Sponsor stops the study, whichever comes first. Adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Tumor response will be assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) scan using RECIST 1.1 criteria, assessed by the investigator.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
TR64 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons.
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
RECRUITINGThe First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGAdverse Events and Serious Adverse Events
Frequency, duration and severity of Adverse Events and Serious Adverse Events evaluated by NCI CTCAE v5.0
Time frame: From the first dose to within 28 days after the last dose
Dose limited toxicities
Incidence of dose limited toxicities
Time frame: within 28 days after the first dose
Maximum tolerated dose
Evaluated by safety review committee
Time frame: Throughout the study for approximately 2 years
Recommended phaseII dose
Evaluated by safety review committee
Time frame: Throughout the study for approximately 2 years
AUClast
Characterize the pharmacokinetic profile of TR64
Time frame: within 35 days after the first dose
AUCinf
Characterize the pharmacokinetic profile of TR64
Time frame: within 35 days after the first dose
Cmax
Characterize the pharmacokinetic profile of TR64
Time frame: within 35 days after the first dose
Tmax
Characterize the pharmacokinetic profile of TR64
Time frame: within 35 days after the first dose
CL/F
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Characterize the pharmacokinetic profile of TR64
Time frame: within 35 days after the first dose
Vz/F
Characterize the pharmacokinetic profile of TR64
Time frame: within 35 days after the first dose
Terminal half-life (T1/2)
Characterize the pharmacokinetic profile of TR64
Time frame: within 35 days after the first dose