To evaluate the efficacy and safety of SPH7485 tablets in patients with advanced solid tumors.
Histologically or cytologically confirmed advanced solid tumors；
At least one extracranial measurable lesion;
ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1;
Subjects whose laboratory examination indicators meet the prescribed standards during the screening period;
Subjects who have received the prescribed other anti-tumor treatments at the prescribed time prior to the first dose;
Subjects who have received previous drugs with the same target;
Subjects with active infections requiring systemic treatment;
Subjects with third gap fluid accumulation that cannot be controlled by drainage or other methods;
Single group
SPH7485
DrugSPH7485： Orally, once daily, 50-400mg, 21 days per cycle
DLT(Dose-limiting toxicity)
Measurement of DLT of SPH7485 in all subjects
Maximum tolerated dose（MTD）
Measurement of MTD of SPH7485 in all subjects
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
ORR(Objective Response Rate)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
DoR(Duration of response)
DOR was defined as the time interval between the date of the first documented response (CR or PR) and the date of the first documented disease progression or death due to any cause
DCR(Disease Control Rate)
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
PFS(Progression-free survival)
PFS was defined as the time interval between study treatment initiation and the first occurrence of progression disease or death, whichever occurred first.
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