A Phase 1 Study of the CD73 Inhibitor(HLX23) Alone in Participants With Solid Tumor

Exclusion Criteria

• •1. Patients who still have ≥ grade 2 toxicities from prior therapies;
• •2. Patients who have history of allergic reaction to monoclonal antibodies;
• •3. Concurrent unstable or uncontrolled medical conditions;
• •4. Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix (patients with previous history of malignancy but without evidence of disease for ≥ 3 years can participate in the study);
• •5. History of prior treatment with anti-CD73 antibodies,including patients treated with adenosine receptor antagonists, CD39 or CD73 inhibitors ;
• •6. Patients with active autoimmune disease, except vitiligo or cured childhood asthma/allergies that requires no intervention after adulthood, autoimmune-mediated hypothyroidism treated with stable doses of thyroid hormone replacement, or Type I diabetes treated with stable doses of insulin can be excepted. Patients in a stable state and do not require systemic immunosuppressive therapy (including corticosteroids) are allowed to be enrolled;
• •7. Pregnancy or breast-feeding;
• •8. Known history of human immunodeficiency virus infection (HIV), but the patients with CD4+ T-cell (CD4+) counts ≥ 350 cells/uL are allowed to be enrolled.
• •9. hepatitis B virus carrier status (HBV surface antigen positive) and hepatitis C carrier (anti-HCV antibody positive). If HBsAg (+) or HBcAb (+), the HBV-DNA≥2500copy/mL or 500 IU/mL, or clinically judged active hepatitis; Subjects co-infected with hepatitis B and hepatitis C should be excluded (positive HBsAg or HBcAb test and positive HCV antibody test);
• •10. The patient is the investigator, sub-investigator or anyone directly involved in the conduct of the study;
• •11. History or current evidence of any condition or disease that could confound the results of the study, or participation is not in the best interest of the patient in the opinion of the Investigator(s).