This is an open-label, multi-center phase I clinical study to evaluate HRS-6093 Safety, Tolerability, and Pharmacokinetics in Participants harboring KRAS G12D Mutations with advanced solid tumors. The study consists of dose escalation, dose expansion and efficacy expansion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
153
HRS-6093
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGWest China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGIncidence and severity of adverse events/serious adverse events (graded as per CTCAE v5.0).
Time frame: Screening Period to 30 Days After the Last Dose
DLT,
Time frame: from day1 to day 23; 23 Days
MTD,
Time frame: from day1 to day 23; 23 Days
RP2D ,
Time frame: 24 months
Number of Participants With Abnormal Laboratory Values
Time frame: Screening Period to 30 Days After the Last Dose; 24 months
Number of subjects with clinically significant changes in ECOG, vital signs and physical examination.
Time frame: Screening Period to 30 Days After the Last Dose; 24 months
Number of subjects with changes on ECG.
Time frame: Screening Period to 30 Days After the Last Dose; 24 months
maximum plasma concentration (Cmax),
Time frame: Screening Period to Day of the end of treatment/withdrawal. 24 months
time to maximum concentration (Tmax),
Time frame: Screening Period to Day of the end of treatment/withdrawal. 24 months
area under concentration-time curve from time 0 to the last measurable concentration time point t (AUC0-t),
Time frame: Screening Period to Day of the end of treatment/withdrawal. 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Area under concentration-time curve from time 0 to infinity (AUC 0-∞), apparent volume of distribution (Vz/F),
Time frame: Screening Period to Day of the end of treatment/withdrawal. 24 months
elimination half-life (t1/2), and apparent clearance (CL/F);
Time frame: Screening Period to Day of the end of treatment/withdrawal. 24 months
minimum concentration at steady state (Cmin, ss),
Time frame: Screening Period to Day of the end of treatment/withdrawal. 24 months
area under the blood concentration-time curve at steady state (AUCss), and accumulation ratio (Rac);
Time frame: Screening Period to Day of the end of treatment/withdrawal. 24 months
objective response rate (ORR),
Time frame: Screening Period to PD; 24 months
duration of response (DoR),
Time frame: Screening Period to PD; 24 months
disease control rate (DCR),
Time frame: Screening Period to PD; 24 months
progression-free survival (PFS),
Time frame: Screening Period to PD; 24 months
overall survival (OS).
Time frame: Screening Period to Day of death of the participant;24months