A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of SPH6516 Tablets in Subjects With Advanced Solid Tumors.

SPH6516-101

To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SPH6516 tablets in the treatment of advanced solid tumors.

2022-01-20

2023-04-20

2023-11-01

Completed

Early phase I

16

Inclusion Criteria: 1. Advanced solid tumors; 2. The ECOGscore is 0 to 1. 3. Expected survival ≥3 months. 4. Good organ function before first use of the investigational drug. 5. Any toxicity associated with previous antitumor therapy must have returned to ≤ grade 1. 6. Voluntarily participate in this clinical trial, understand the research procedures and be able to sign the informed consent in person. Exclusion Criteria: 1. Subjects who have received certain treatment in the prescribed period prior to their first medication; 2. Subjects who have undergone major surgery within 6 weeks before the first medication, or who plan to undergo major surgery within 12 weeks after the first medication; 3. Subjects who have participated in any other clinical trials and received treatment within 4 weeks prior to the first medication; 4. Subjects with third space fluid accumulation that cannot be controlled by drainage or other methods; Subjects with factors affecting drug administration and absorption; 5. Subjects with allergic constitution or a history of severe allergies; 6. Subjects with active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, or a history of immunodeficiency; 7. Subjects with a history or evidence of high risk cardiovascular disease; 8. Subjects with severe lung disease; 9. Pregnant and lactating female subjects; Female subjects of childbearing age or male subjectswith fertile partners who were unwilling to take effective contraceptive measures throughout the entire trial period; 10. Subjects with a clear history of neurological or psychiatric disorders; 11. Other situations in which the investigator did not consider it appropriate to participate in the study.

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2024-02-20