An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Selected Advanced Tumors

Eligibility Criteria

• 1. Able to understand and be willing to sign the ICF.
• 2. Male and female subjects of ≥18 years of age.
• 3. Histologically/cytologically confirmed, locally advanced solid tumor:
• 4. For subjects with advanced solid tumors - 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 classical Hodgkin lymphoma - must have classical Hodgkin lymphoma that is measurable or assessable for response.
• 6. Must have ECOG performance status of 0 to 1 at Screening.
• 7. Able to provide tumor tissue samples.
• 8. Have a life expectancy of ≥12 weeks.
• 1. With known history of hypersensitivity to any components of HCB301.
• 2. Known active or untreated CNS metastases and/or carcinomatous meningitis.
• 3. Have undergone a major surgery or radical radiotherapy within 28 days or palliative radiotherapy within 14 days or have used a radioactive drug within 56 days prior to the first dose of HCB301.
• 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 administered within 21 days or 5 half-lives, whichever is shorter, before the first dose of the study drug.
• 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 ≤ 100 mg/QD.
• 11. Have used herbal medication within 14 days prior to the first dose of HCB301.
• 12. Have received any treatment targeting the SIRPα-CD47, PD-L1, or TGF-β pathway.
• 13. Have other malignancies requiring treatment within 2 years prior to the first dose of HCB301.
• 14. An investigational device used within 28 days prior to the first dose of HCB301.
• 15. Positive for hepatitis B, active hepatitis C infections, positive for HIV, or known active or latent tuberculosis.
• 16. Known to have a history of alcoholism or drug abuse.