This phase I trial is testing a new drug (KN046) in patients with advanced cancers who are not able to have any other standard therapiesAn Open-Label, Multi-center, Dose-Escalation Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics and Immunogenicity of KN046 in Subjects With Advanced Solid Tumors

Exclusion

1. Subjects with brain metastases or leptomeningeal are excluded.
2. Concurrent enrollment in another clinical study, unless in a follow-up period or the study is an observational or non-interventional study.
3. Any kind of immunotherapy within 6 weeks of the first dose of study treatment.
4. Prior systemic cytotoxic chemotherapy, other anticancer drugs or growth factor within 28 days of the first dose of study treatment, or any investigational agents within 5 half-lives of the product.
5. Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the 1st dose of study treatment, or have an anticipated need for major surgery during the study.
6. Palliative radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the 1st dose of study treatment.
7. Prior treatment or with sequential monotherapy with anti-CTLA-4 and anti-PD-1/PD-L agents.
8. Patients who have received monotherapy with PD-L1 / PD-1, CTLA4 or other antibodies and had intolerable toxicity or required steroids to manage toxicity.
9. History of autoimmune or inflammatory disorders.
10. A current or prior use of immunosuppressive medication within 14 days of the 1st dose of study treatment.
11. Suspected latent tuberculosis infection, confirmed by Mantoux test and a chest x-ray.
12. Any unresolved toxicity NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
13. Any factors that increase the risk of QT (ECG interval measured from the onset of the QRS complex to the end of the T wave) interval corrected for heart rate (QTc) prolongation or risk of arrhythmic events (e.g., heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age) or mean QTc>470 msec.
14. Positive blood screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus 1/2 antibody (HIV 1/2 Ab).
15. History of severe allergic reactions to any unknown allergens or to parenteral administered recombinant protein product.