A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors

Exclusion Criteria

• •1. With known history of hypersensitivity to any components of HCB101.
• •2. Known active or untreated CNS metastases and/or carcinomatous meningitis.
• •3. Have undergone a major surgery or radical radiotherapy or palliative radiotherapy or have used a radioactive drug that is not completed at least 2 weeks prior to the first dose of HCB101.
• •4. Clinically significant cardiovascular condition.
• •5. Any previous treatment-related toxicities which have not recovered to ≤ Grade 1 as evaluated by National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 or baseline, except alopecia and anemia.
• •6. With known inherited or acquired bleeding disorder or bleeding diathesis. .
• •7. Have RBC transfusion within 4 weeks prior to Screening.
• •8. With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the last 3 months.
• •9. Any investigational or approved systemic cancer therapy.
• •10. Active use of vitamin K antagonist anticoagulant like warfarin. Use of low molecular weight heparin and factor Xa inhibitors will be permitted on case by case basis. There will be no restriction for daily aspirin ≤ 81 mg/QD.
• •11. Have used herbal medication within 14 days prior to the first dose of HCB101.
• •12. Have received any treatment targeting the CD47 or SIRPα pathway.
• •13. Have other malignancies requiring treatment within 2 years prior to the first dose of HCB101.
• •14. Participation in another clinical study with an investigational product administered in the last 14 days prior to receiving the first dose of HCB101.
• •15. An investigational device used within 28 days prior to the first dose of HCB101.
• •16. Positive for hepatitis B, active hepatitis C infections, positive for HIV, or known active or latent tuberculosis.
• •17. Known to have a history of alcoholism or drug abuse.