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    DRUG:

    HCB101

    i
    Other names: HLX701, HLX-701, HLX 701, HCB101, HCB 101, HCB-101
    Associations

    News

    Trials
    Company:
    Fosun Pharma, HanchorBio
    Drug class:
    CD47 inhibitor
    Related drugs:
    Associations

    News

    Trials
    1m
    HCB101: a novel potent ligand-trap Fc-fusion protein targeting the CD47-SIRPα pathway with high safety and preclinical efficacy for hematological and solid tumors. (PubMed, J Hematol Oncol)
    HCB101 demonstrates high-affinity binding to CD47, robustly promotes macrophage-mediated phagocytosis of tumor cells without affecting red blood cells and exhibits unique advantages over current CD47-targeting agents, including Hu5F9-G4, TTI-622, and ALX148. Additionally, HCB101 treatment increased the M1/M2 macrophage ratio in the tumor microenvironment, suggesting repolarization of tumor-associated macrophages (TAMs) toward a pro-inflammatory phenotype. No dose-limiting toxicities or hematologic adverse effects were observed in murine or non-human primate studies.
    Preclinical • Journal • IO biomarker
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    CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
    |
    magrolimab (ONO-7913) • evorpacept (ALX148) • HCB101 • maplirpacept (TTI-622)
    2ms
    The Phase 1b/IIa, Open-label, Dose Escalation and Dose Expansion to Evaluate Safety, Tolerability, and Preliminary Efficacy of the Combination of HCB101, Cetuximab/Bevacizumab, and FOLFOX/FOLFIRI in Advanced or Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=40, Recruiting, Chang Gung Memorial Hospital
    New P1/2 trial
    |
    Avastin (bevacizumab) • Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • HCB101
    3ms
    A Phase I/II Trial of HCB101 in Combination With Pembrolizumab for Patients With Platinum-Refractory, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SirH&N Trial) (clinicaltrials.gov)
    P1/2, N=50, Recruiting, Taipei Veterans General Hospital, Taiwan
    New P1/2 trial
    |
    Keytruda (pembrolizumab) • HCB101
    5ms
    A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors (clinicaltrials.gov)
    P1, N=60, Recruiting, FBD Biologics Limited | Trial completion date: Nov 2025 --> Nov 2029 | Trial primary completion date: May 2025 --> May 2027
    Trial completion date • Trial primary completion date
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    HCB101
    8ms
    Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=150, Recruiting, FBD Biologics Limited | Not yet recruiting --> Recruiting
    Enrollment open
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    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Herceptin (trastuzumab) • Erbitux (cetuximab) • carboplatin • gemcitabine • 5-fluorouracil • Perjeta (pertuzumab) • Loqtorzi (toripalimab-tpzi) • capecitabine • albumin-bound paclitaxel • Cyramza (ramucirumab) • oxaliplatin • irinotecan • leucovorin calcium • HCB101
    11ms
    Safety and Efficacy of HCB101 in Combination with Multiple Agents in Patients with Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=150, Not yet recruiting, FBD Biologics Limited
    New P1/2 trial
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Herceptin (trastuzumab) • Erbitux (cetuximab) • carboplatin • gemcitabine • 5-fluorouracil • Perjeta (pertuzumab) • Loqtorzi (toripalimab-tpzi) • capecitabine • albumin-bound paclitaxel • Cyramza (ramucirumab) • oxaliplatin • irinotecan • leucovorin calcium • HCB101
    over2years
    A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors (clinicaltrials.gov)
    P1, N=60, Not yet recruiting, FBD Biologics Limited
    New P1 trial • Metastases
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    HCB101