A Study for HSK39775 in Participants With Solid Tumors

Inclusion criteria

• Age 18 years or older at screening
• Histological or cytological confirmation of advanced malignancy, have failed or intolerant to the standard-of-care treatment or no standard therapy is recognized or standard therapy is unavailable
• Eastern Cooperative Oncology Group performance status 0 or 1
• Patients must have evaluable disease as defined
• Life expectancy of ≥ 12 weeks
• Adequate organ and bone marrow function per protocol
• Female patients who are women of childbearing potential with confirmed of a negative pregnancy test within 7 days prior to the first dose and agreement to the use of effective contraceptive method at the same time during study treatment period and for up to 6 months after the last dose of study treatment. Male patients must be willing to use effective contraception during the study treatment period and for up to 6 months after the last dose of study treatment
• Written informed consent must be obtained

Exclusion criteria

• Known allergies to HSK39775 or its excipients
• Prior anticancer treatment is ineligible per protocol
• Subjects who have had continuous corticosteroids at a dose of >10 mg prednisone/day or equivalent within 4 weeks prior to the first dose of study treatment
• Subjects who have had live vaccine within 4 weeks prior the first dose of study treatment
• Currently participating in a study of another investigational agent or device
• Subjects who have had received another agent with same target
• Subjects who have not recovered (to grade ≤1 or baseline) from toxicities related to prior therapies
• Subjects who have had received drugs that may have drug-drug interaction potential within 4 weeks or 5 half-lives prior to the first dose of study treatment
• Subjects who have had received major surgery within 4 weeks prior the first dose of study treatment
• Central nervous system metastases associated with neurological symptoms
• Active hepatitis B or hepatitis C infection
• A history of immunodeficiency
• Clinically relevant cardiovascular disease as delined by protocol
• Inability to swallow the formulated product or impairment of GI function or disease that may significantly alter the absorption of study drug
• A female patient who is pregnant or lactating
• Other conditions, in investigator's opinion, not suitable to participate in the clinical study