This is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion. Participants entering the study will receive HRS-8080 combined with Dalpiciclib Isethionate Tablets therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
146
HRS-8080 combined with Dalpiciclib Isethionate Tablets
Chinese PLA General Hospital Fifth Medical Center
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, China
RECRUITINGDose-limiting toxicity (DLT)
Time frame: About 2 years
Maximum tolerated dose (MTD)
Time frame: About 2 years
Recommended phase II dose (RP2D)
Time frame: About 2 years
Safety endpoints: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: About 2 years
Outcome endpoint: Objective Response Rate (ORR)
Time frame: About 2 years
Steady-state peak concentration (Cmax,ss)
Time frame: About 2 years
Steady-state peak time (Tmax,ss)
Time frame: About 2 years
Steady-state valley concentration (Cmin,ss)
Time frame: About 2 years
Steady-state blood drug concentration-time curve area (AUCss)
Time frame: About 2 years
Best overall response (BOR)
Time frame: About 2 years
Duration of response (DoR)
Time frame: About 2 years
Disease control rate (DCR)
Time frame: About 2 years
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Clinical benefit rate (CBR)
Time frame: About 2 years
Progression-free survival (PFS)
Time frame: About 2 years