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

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.

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Publication Details

Journal
ESMO Open
Published
2026-04-01
DOI
https://doi.org/10.1016/j.esmoop.2026.106202
Primary Topic
Phagocytosis and Immune Regulation
Type
article
Field-Weighted Citation Impact
0.00
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article

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

Nicholas Iannotti, C-C. Lin, W-H. Cheng, T. Zhang et al.
ESMO Open
Phagocytosis and Immune Regulation
article

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

Nicholas Iannotti, C-C. Lin, W-H. Cheng, T. Zhang, F. Mo, P.M-H. Chang, J. Zhang, A. Luk, A. Yu, J. Ma, Y. Wang, F. Ning, W. Edenfield, W. Li
article en

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.

ESMO OpenVol. 11
Prisma Health (US), Shandong University of Aeronautics (CN), Taipei Veterans General Hospital (TW), Fudan University Shanghai Cancer Center (CN), Southwestern Medical Center (US), National Taiwan University Hospital (TW), Hematology Oncology Associates (US), Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine (CN), Guangdong Provincial People's Hospital (CN), Shanghai Clinical Research Center (CN), Taipei Medical University-Shuang Ho Hospital (TW), Shandong First Medical University (CN), The University of Texas Southwestern Medical Center (US)
Good health and well-being
Openalex Percentile: Top 38%
Phagocytosis and Immune Regulation
DOIOpen Access PDFOpenAlex
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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 — Nicholas Iannotti, C-C. Lin, et al. · ESMO Open (2026) | TGRS Research Map | TGRS