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    DRUG:

    anzurstobart (BMS-986351)

    i
    Other names: BMS-986351, CC 95251, CC-95251
    Company:
    BMS
    Drug class:
    SIRPA antagonist
    Related drugs:
    2ms
    CC-95251-ST-001: A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers (clinicaltrials.gov)
    P1, N=206, Terminated, Celgene | Active, not recruiting --> Terminated; Business objectives have changed.
    Trial termination • Combination therapy • Metastases
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Erbitux (cetuximab) • Rituxan (rituximab) • anzurstobart (BMS-986351)
    2ms
    A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes (clinicaltrials.gov)
    P1, N=56, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed | N=218 --> 56 | Trial completion date: Jun 2026 --> Jul 2024 | Trial primary completion date: Jun 2026 --> Jul 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    Venclexta (venetoclax) • azacitidine • anzurstobart (BMS-986351)
    8ms
    A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes (clinicaltrials.gov)
    P1, N=218, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Venclexta (venetoclax) • azacitidine • anzurstobart (BMS-986351)
    9ms
    Discovery and Preclinical Activity of BMS-986351, an Antibody to SIRPα that Enhances Macrophage-Mediated Tumor Phagocytosis when Combined with Opsonizing Antibodies. (PubMed, Cancer Res Commun)
    In vitro, BMS-986351 increased phagocytic activity against cell lines from solid tumors and hematological malignancies, and this effect was markedly enhanced when BMS-986351 was combined with the opsonizing antibodies cetuximab and rituximab. A phase I dose escalation/ expansion study of BMS-986351 for the treatment of advanced solid and hematologic malignancies is underway (NCT03783403).
    Preclinical • Journal
    |
    CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
    |
    CD47 overexpression • CD47 expression
    |
    Erbitux (cetuximab) • Rituxan (rituximab) • anzurstobart (BMS-986351)
    12ms
    CC-95251-ST-001: A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers (clinicaltrials.gov)
    P1, N=230, Active, not recruiting, Celgene | Trial completion date: Aug 2025 --> Aug 2024
    Trial completion date • Combination therapy • Metastases
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Erbitux (cetuximab) • Rituxan (rituximab) • anzurstobart (BMS-986351)
    over1year
    CC-95251-ST-001: A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers (clinicaltrials.gov)
    P1, N=230, Active, not recruiting, Celgene | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Erbitux (cetuximab) • Rituxan (rituximab) • anzurstobart (BMS-986351)
    over2years
    FIRST CLINICAL STUDY OF THE ANTI-SIGNAL REGULATORY PROTEIN-ALPHA (SIRPΑ) ANTIBODY CC-95251 COMBINED WITH RITUXIMAB IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) NON-HODGKIN LYMPHOMA (NHL) (EHA 2022)
    Conclusion CC-95251 + ritux demonstrated a manageable safety profile and promising efficacy in pts with heavily pretreated CD20+ R/R NHL. The study is currently enrolling in the dose-expansion phase.
    Clinical
    |
    CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
    |
    Rituxan (rituximab) • anzurstobart (BMS-986351)
    over2years
    CC-95251-ST-001: A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers (clinicaltrials.gov)
    P1, N=230, Recruiting, Celgene | Trial completion date: Nov 2024 --> Aug 2025 | Trial primary completion date: Nov 2022 --> Jun 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Erbitux (cetuximab) • Rituxan (rituximab) • anzurstobart (BMS-986351)
    3years
    Interim Results from the First Clinical Study of CC-95251, an Anti-Signal Regulatory Protein-Alpha (SIRPα) Antibody, in Combination with Rituximab in Patients with Relapsed and/or Refractory Non-Hodgkin Lymphoma (R/R NHL) (ASH 2021)
    CC-95251-ST-001 (NCT03783403) is a multicenter, open-label, phase 1, dose-escalation and expansion study of CC-95251 in pts with advanced solid tumors and CD20+ R/R NHL. CC-95251, a novel anti-SIRPα antibody, demonstrated a manageable safety profile and promising efficacy in combination with rituximab in pts with heavily pretreated CD20+ R/R NHL. The study continues to enroll in the dose-expansion phase. Updated safety and efficacy data will be presented.
    Clinical • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
    |
    Rituxan (rituximab) • anzurstobart (BMS-986351) • fenretinide nanoparticle (ST-001 nanoFenretinide)
    3years
    Discovery and Preclinical Characterization of CC-95251, an Anti-SIRPα Antibody That Enhances Macrophage-Mediated Phagocytosis of Non-Hodgkin Lymphoma (NHL) Cells When Combined with Rituximab (ASH 2021)
    These results support the clinical evaluation of CC-95251 + rituximab for relapsed or refractory NHL. A phase 1 dose-escalation and -expansion study of CC-95251 for the treatment of advanced solid and hematologic malignancies is underway (NCT03783403).
    Preclinical
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD47 (CD47 Molecule) • CD163 (CD163 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
    |
    Rituxan (rituximab) • anzurstobart (BMS-986351)