KN046 in Subjects With Advanced Solid Tumors and Lymphoma

Inclusion criteria

• Signed informed consent; willing and able to complete all required procedures of study.
• With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
• Subjects must have at least one measurable lesion in advanced solid tumors, at least one measurable or assessable lesion in NK/T cell lymphoma.
• ECOG performance status of 0 or 1.
• Subject must have adequate organ function.
• Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
• Ability to comply with treatment, procedures and PK sample collection and the required study follow-up procedures.

Exclusion criteria

• Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
• Is currently participating or has participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment.
• Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
• Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
• Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
• Active HBV or HCV infection.
• Known HIV infection or known history of acquired immune deficient syndrome (AIDS).
• Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
• Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.