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

Eligibility Criteria

• 1. Able to understand and willing to sign the ICF.
• 2. Male and female subjects of ≥18 years of age.
• 3. Histologically/cytologically confirmed, locally advanced solid tumor: subjects with histologically or cytologically confirmed advanced solid tumors refractory to standard therapy, or for which no standard treatment exists or non-Hodgkin lymphoma, relapsed or refractory to at least 2 prior lines of therapy.
• 4. For subjects with advanced solid tumor - must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline.
• 5. For subjects with non-Hodgkin lymphoma - must have non-Hodgkin lymphoma that is measurable or assessable for response per Lugano Classification (with 2016 refinement).
• 6. Must have ECOG performance status of 0 to 2 at Screening.
• 7. Able to provide tumor tissue samples.
• 8. Have life expectancy of ≥12 weeks.
• 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.