Recombinant Humanized Anti-CD47 / PD-1 Bifunctional Antibody HX009 Injection in the Treatment of Advanced Solid Tumors

Exclusion Criteria

• •1. Participants having a known additional malignancy within 5 years before enrollment, except for malignancies with low risk of metastasis and death (5-year survival rate\> 90%), such as completely resected basal cell or squamous cell skin cancer, or cervical carcinoma in situ, or superficial bladder cancer,early breast cancer with low risk of recurrence, etc;
• •2. Adverse reactions related to previous treatment that failed to recover to CTCAE 5.0 ≤ grade 1 (chemotherapy-induced alopecia or grade 2-3 peripheral neurotoxicity are eligible; immune-related grade 2-3 hypothyroidism is eligible)；
• •3. Participants with active or history of autoimmune diseases are ineligible, except for the following conditions:
• •* Participants with type 1 diabetes who are in stable condition after using a fixed dose of insulin;
• •* Autoimmune hypothyroidism requiring only hormone replacement therapy;
• •* Autoimmune skin diseases that do not require systemic treatment (such as eczema, skin rashes that account for less than 10% of the body surface, or psoriasis without ophthalmological symptoms);
• •4. Participants expected to undergo major surgery within 28 days before the planned first dose of HX009;
• •5. Participants receiving systemic corticosteroids equivalent to \>10 mg prednisone/day or other immunosuppressive drugs within 14 days before the first administration of HX009, except for the following conditions:
• •* Participants using topical or inhaled corticosteroids;
• •* Short-term (≤7 days) use of glucocorticoids equivalent to ≤10 mg of prednisone daily for the prevention or treatment of non-autoimmune allergic diseases is permitted;
• •6. Participants with known interstitial lung disease or non-infectious pneumonia requiring systemic treatment with glucocorticoids;
• •7. Participants having clinically serious cardiovascular diseases (unstable angina or myocardial infarction within 6 months before enrollment), diabetes, or hypertension;
• •8. Participants having a history of human immunodeficiency virus infection, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;
• •9. Patients with active chronic hepatitis B or active hepatitis C. Hepatitis B virus carriers, stable hepatitis B after drug treatment (DNA titer not higher than 500 IU/mL or copy number \<1000 copies/ml) and cured hepatitis C patients (HCV RNA test negative) can be enrolled;
• •10. Participants having a serious infection within 4 weeks before the first administration of HX009, or having an active infection that require oral or intravenous antibiotic treatment;
• •11. Participants having severe allergic reactions to macromolecular protein preparations/monoclonal antibodies, or to any drug component of HX009 (CTCAE 5.0 grade greater than 3);
• •12. Participated in other drug clinical trials within 4 weeks before the first administration of HX009;
• •13. Alcohol dependent or known history of drug abuse within the past year;
• •14. Participants with poor compliance due to known history of neurological or mental disorders, such as epilepsy, dementia;
• •15. Pregnant or breastfeeding women;
• •16. Participants with pleural effusion, abdominal effusion or pericardial effusion with clinical symptoms;
• •17. Those who have received blood transfusion therapy within 4 weeks before the start of treatment or received hematopoietic stimulating factor therapy within 2 weeks, such as colony stimulating factor, erythropoietin, thrombopoietin, etc.;
• •18. According to the investigator's judgment, the subjects have other factors that may cause them to be forced to terminate the study halfway, such as serious diseases requiring concomitant treatment, family or social factors, which may affect the safety of the subjects or the collection of experimental data.