This is a Phase Ib, open-label, multicenter study of HSK41959 tablets in combination with standard therapy in patients with MTAP-deficient advanced solid tumors. The study consists of dose-escalation and dose-expansion parts and is intended to evaluate the safety, tolerability, dose-limiting toxicity, maximum tolerated dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HSK41959 tablets when used together with standard therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
258
Oral administration, QD
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
DLTs
DLTs assessed during the protocol-defined DLT evaluation period.
Time frame: 21 days for NSCLC cohorts; 28 days for PDAC cohorts
AEs
Rate and severity of adverse events of HSK41959 Tablets in Combination With Standard Therapy
Time frame: Up to approximately 3 years
Overall response rate (ORR)
ORR, defined as the proportion of patients who experience a best response of confirmed CR or PR according to RECIST 1.1
Time frame: Up to approximately 3 years
Disease control rate (DCR)
DCR, defined as the proportion of patients who experience a best response of CR, PR, or stable disease (SD) according to RECIST 1.1
Time frame: Up to approximately 3 years
Progression free survival (PFS)
PFS, defined as the time frocease or death due to any cause, whichever occurs first
Time frame: Up to approximately 3 years
Overall survival (OS)
OS, defined as the time from the first dose of HSK41959 until the date of death due to any cause
Time frame: Up to approximately 3 years
Area under the curve (AUC) of HSK41959 Tablets in Combination With Standard Therapy
Time frame: Up to approximately 6 months
maximum plasma concentration (Cmax) of HSK41959 Tablets in Combination With Standard Therapy
Time frame: Up to approximately 6 months
Tmax(Time to maximum plasma concentration) of HSK41959 Tablets in Combination With Standard Therapy
Time frame: Up to approximately 6 months
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