This research is designed to determine if HSK39775 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
243
HSK39775 will be administered orally once daily
Fundan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGAE/SAE
Safety data
Time frame: From time of informed consent to 28 days post last dose or start of other anti-cancer therapies
DLT
Safety data
Time frame: From the start of first dose to the end of Cycle1(each cycle is 28 days)
MTD/MAD
Safety data
Time frame: From the start of first dose to the end of Cycle1(each cycle is 28 days)
Maximum Plasma Concentration [Cmax]
Time frame: At predefined intervals throughout the treatment period(approximately 12 weeks)
Area Under Curve[AUC]
Time frame: At predefined intervals throughout the treatment period(approximately 12 weeks)
Time to maximum observed concentration [Tmax]
Time frame: At predefined intervals throughout the treatment period(approximately 12 weeks)
Elimination half-life [t1/2]
Time frame: At predefined intervals throughout the treatment period(approximately 12 weeks)
Overall Response Rate (ORR) per RECIST V1.1
Time frame: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
Progression Free Survival
Time frame: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
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Time To Response
Time frame: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
Disease Control Rate
Time frame: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]
Best percentage change in target lesion
Time frame: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]