This is a phase I study of HRS-7172 to evaluate safety, tolerability and pharmacokinetics in participants with advanced solid tumors harboring RAS mutations or amplifications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
HRS-7172 tablets.
Fudan University Affiliated Cancer Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence and severity of adverse events (AEs)
Time frame: From screening period up to 30 days after the last dose.
Incidence and severity of serious adverse events (SAEs)
Time frame: From screening period up to 30 days after the last dose.
Dose-limiting toxicity (DLT)
Time frame: From day 1 to day 24.
Maximum tolerated dose (MTD)
Time frame: From day 1 to day 24.
Recommended Phase II Dose (RP2D)
Time frame: From day 1 to day 24.
Objective response rate (ORR)
Time frame: About 24 months.
Duration of response (DoR)
Time frame: About 24 months.
Disease control rate (DCR)
Time frame: About 24 months.
Progression-free survival (PFS)
Time frame: About 24 months.
Overall survival (OS)
Time frame: About 24 months.
Maximum plasma concentration (Cmax)
Time frame: About 24 months.
Time to maximum concentration (Tmax)
Time frame: About 24 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Elimination half-life (t1/2)
Time frame: About 24 months.
Area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t)
Time frame: About 24 months.
Area under concentration-time curve from time 0 to infinity (AUC0-∞)
Time frame: About 24 months.