This is an open-label, multi-center phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of HRS-2329 in participants with advanced solid tumors harboring RAS mutations or amplifications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Oral HRS-2329 tablet.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Incidence and severity of adverse events (AEs).
Graded as per CTCAE v5.0.
Time frame: From the screening period to 30 days after the last dose.
Incidence and severity of serious adverse events (SAEs).
Graded as per CTCAE v5.0.
Time frame: From the screening period to 30 days after the last dose.
Dose-limiting toxicity (DLT).
Time frame: From Day 1 to Day 21.
Maximum tolerated dose (MTD).
Time frame: From Day 1 to Day 21.
Recommended Phase II Dose (RP2D).
Time frame: 24 months.
Maximum plasma concentration (Cmax).
Time frame: About 24 months.
The time to maximum concentration (Tmax).
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 (AUC 0-∞).
Time frame: About 24 months.
Apparent volume of distribution (Vz/F).
Time frame: About 24 months.
Elimination half-life (t1/2).
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Time frame: About 24 months.
Apparent clearance (CL/F).
Time frame: About 24 months.
Minimum concentration at steady state (Cmin, ss).
Time frame: About 24 months.
Area under the blood concentration-time curve at steady state (AUCss).
Time frame: About 24 months.
Accumulation ratio (Rac).
Time frame: About 24 months.
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.