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61O First-in-human phase I evaluation of HCB101, a SIRPα–Fc innate checkpoint fusion protein: Safety, pharmacokinetics, and receptor occupancy

Year: 2026
Type: article
Study design: Clinical Trial
Abstract: HCB101 is a rationally engineered SIRPα-Fc fusion protein designed to improve the safety and activity of CD47 pathway inhibition through reduced red-blood-cell binding, minimized cytopenias, and enhanced macrophage activation. Preclinical studies in >80 xenograft and PDX models demonstrated potent CD47–SIRPα blockade, strong innate immune activation, and a broad therapeutic window. This first-in-human study evaluates the safety, pharmacokinetics (PK), receptor occupancy (RO), and pharmacodynamic (PD) effects of HCB101 in advanced cancers.
Source: ESMO Open
DOI: 10.1016/j.esmoop.2026.106202
Authors: F. Ning, N. Iannotti, W-H. Cheng, J. Ma, C-C. Lin, Y. Wang, P.M-H. Chang, W. Edenfield, W. Li, T. Zhang, J. Zhang, F. Mo, A. Yu, A. Luk
Institutions: Binzhou Medical University, Taipei Medical University-Shuang Ho Hospital, Taipei Medical University, Shandong First Medical University, National Taiwan University Hospital, Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine, Taipei Veterans General Hospital, Prisma Health, Guangdong Provincial People's Hospital, The University of Texas Southwestern Medical Center, Fudan University Shanghai Cancer Center
Language: English
Subfield: Immunology
Open Access status: gold
Estimated APC paid: $3,910
OpenAlex ID: W7147054473
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