A Study of CS231295 in Patients With Advanced Solid Tumors

In this dose-escalation study, the "3+3" design will be employed for dose escalation decisions. 4 dose groups have been preset: 20 mg, 30 mg, 40 mg, 50 mg\[LA2.1\]. The starting dose is 20 mg, with each dose cohort enrolling 3-6 subjects. Each subject can participate in only one dosage group of the study. During the dose escalation, depending on the observed results of safety, pharmacokinetics (PK), and pharmacodynamics (PD), dose levels may be adjusted or removed, additional dose levels may be added and explored, including intermediate or higher dose levels or other dosing regimens. The dose escalation study includes a single-dose treatment period (C0) and a multiple-dose treatment period (C1, C2, …). During the treatment, subjects will first undergo a 6-day single-dose treatment period. Each subject will receive a single dose of oral CS231295 on Day 1 of the study, with no additional doses administered through Day 6. All subjects in each cohort (3 to 6 subjects) will initiate this single-dose period, followed by a continuous multiple-dose treatment period with a treatment cycle of 28 days and no drug-free intervals. Patients continue the treatment cycle until disease progression per investigator assessment, unacceptable toxicity, death, withdrawal of consent, study termination, or other discontinuation criteria are met (whichever occurs first).