This study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
233
HRS-7058 capsule/ HRS-7058 tablet
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGDose-limiting toxicity (DLT)
Time frame: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
maximum tolerated dose (MTD)
Time frame: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Phase II recommended dose (RP2D)
Time frame: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Safety endpoints: adverse events (AE)
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 21 months]
Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion
Time frame: From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion
Time frame: From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months
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Efficacy endpoints: overall survival (OS)
Time frame: From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months