A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.

Inclusion criteria

• 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;
• Life expectancy≥3 months;
• Subjects whose toxic reactions to previous antitumor therapy returned to baseline or CTCAE≤grade 1;
• Female subjects whose pregnancy tests are negative; Male subjects agree not to donate sperm; Subject and partner agree to use reliable contraception;
• Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Subjects willing to follow and able to complete all test procedures.

Exclusion criteria

• 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;
• Subjects with uncontrolled or severe cardiovascular disease;
• Severe lung disease;
• Subjects with conditions that may affect the absorption, distribution, metabolism, or excretion of the test drug;
• Subjects taking strong/moderate inhibitors or inducers of CYP3A4;
• Subjects who use or require long-term use of hormonotherapy before screening;
• Subjects who have had other malignancies within the past 5 years;
• Subjects with symptomatic CNS metastasis, pial metastasis, or spinal cord compression due to metastasis;
• Subjects who have undergone or are scheduled to undergo major surgery, or have not yet recovered from surgery;
• Abnormal virological examination during screening; History of immune deficiency;
• Uncontrolled systemic diseases;
• Subjects who have participated in any other clinical trial and received treatment within 21 days prior to the first dose;
• Subjects who have received or plan to receive live or attenuated vaccines within 28 days prior to first dose;
• Subjects with a history of severe allergy or known allergy to this product and its excipients;
• Subjects who cannot follow the study protocol to complete the required study visit and dosing;
• Subjects with a history of alcohol or drug abuse;
• Lactating female patients;
• Subjects with a clear past history of neurological or psychiatric disorders. Subjects with primary diseases of other vital organs deemed unsuitable for inclusion by the investigator;
• Subjects deemed unsuitable for this clinical study by the investigator for other reasons.