This study is a multi center, open label, dose increasing/dose expanding/efficacy expanding phase I clinical trial aimed at evaluating the safety, tolerance, PK characteristics, and anti-tumor efficacy characteristics of HRS-2189 single drug in patients with advanced malignant solid tumors. This study was divided into three stages: dose escalation, dose expansion, and efficacy expansion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
HRS-2189 Tablets
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGAEs+SAEs
Time frame: from the first drug administration to within 30 days for the last treatment dose
Dose limited toxicity (DLT) of HRS-2189
Time frame: up to 35 days
Maximum tolerated dose(MTD)of HRS-2189
Time frame: up to 35 days
Recommended Phase II Dose (RP2D) of HRS-2189
Time frame: up to 35 days
Evaluation of pharmacokinetic parameter of HRS-2189: Cmax
Time frame: 2 months
Evaluation of pharmacokinetic parameter of HRS-2189: Tmax
Time frame: 2 months
Evaluation of pharmacokinetic parameter of HRS-2189: AUC0-t
Time frame: 2 months
Evaluation of pharmacokinetic parameter of HRS-2189: AUC0-inf
Time frame: 2 months
Evaluation of pharmacokinetic parameter of HRS-2189: Cmax,ss
Time frame: 2 months
Evaluation of pharmacokinetic parameter of HRS-2189: Tmax,ss
Time frame: 2 months
Evaluation of pharmacokinetic parameter of HRS-2189: Cmin,ss
Time frame: 2 months
Evaluation of pharmacokinetic parameter of HRS-2189: AUCss
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Time frame: 2 months
Evaluation of pharmacokinetic parameter of HRS-2189: Rac
Time frame: 2 months
Bioavailability of HRS-2189 on an empty stomach and after meals
Time frame: up to 9 days
Objective Response Rate (ORR)
Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by CT or MRI
Time frame: every 8 weeks since Day 8 administration,an average of 1 year
Duration of response (DoR)
Time from documentation of tumor response to disease progression assessed among patients who had an objective response
Time frame: every 8 weeks since Day 8 administration,an average of 1 year
Disease control rate (DCR)
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
Time frame: every 8 weeks since Day 8 administration,an average of 1 year
Progression free survival(PFS)
The time from enrollment to the progression of tumors (in any aspect) or death (for any reason)
Time frame: every 8 weeks since Day 8 administration,an average of 1 year