Clinical Research Directory

Inclusion Criteria: * Histologically or cytological confirmed, solid, malignant tumor that is refractory to standard therapy or for which no standard of care regimen currently exists; * At least one assessable tumor lesion according to RECIST v1.1 in dose escalation part of the study ; At least one measurable tumor lesion according to RECIST v1.1 in dose expansion part of the study; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; * Major organ functions are normal, meets pre-specified lab requirements; * Females of reproductive age must have a negative serological hCG test during the screening period; * Subjects of reproductive age (both male and female) must agree to use contraceptive methods from signing Informed Consent to 90 days post the last dose; Exclusion Criteria: * Has received any investigational medicinal product or other systemic anticancer treatment within 4 weeks prior to the first dose of study treatment; * Unable to take medication orally, or has impaired GI function; * Has received systemic glucocorticoids (prednisone\>10 mg/ day or an equivalent dose of another drug of the same class) or other immunosuppressants within 14 days prior to the first dose of study treatment; * Has received live, attenuated vaccines within 4 weeks prior to the first dose of study treatment; * Has active infection that requires intravenous anti-infective therapy; * History of HIV infection, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; * History of serious cardiovascular and cerebrovascular diseases; * History of adverse effect from previous antineoplastic therapy that has not returned to CTCAE grade 5.0 ≤1; * Cerebral parenchymal or meningeal metastasis; * History of ≥ Grade 3 irAE or ≥ Grade 2 myocarditis from previous immune therapy;