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    DRUG:

    izuralimab (XmAb23104)

    i
    Other names: XmAb23104, XmAb 23104, XmAb104
    Associations

    News

    Trials
    Company:
    Xencor
    Drug class:
    PD1 inhibitor, ICOS stimulant
    Related drugs:
    Associations

    News

    Trials
    3ms
    A Study of XmAb23104 in People With Sarcoma (clinicaltrials.gov)
    P2, N=6, Terminated, Memorial Sloan Kettering Cancer Center | Trial completion date: Apr 2025 --> Jul 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Apr 2025 --> Jul 2024; Vendor decided study to be closed early
    Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    izuralimab (XmAb23104)
    6ms
    A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3) (clinicaltrials.gov)
    P1, N=198, Completed, Xencor, Inc. | Active, not recruiting --> Completed | N=300 --> 198 | Trial completion date: Sep 2025 --> Feb 2024 | Trial primary completion date: Dec 2024 --> Feb 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    Yervoy (ipilimumab) • izuralimab (XmAb23104)
    9ms
    XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) in Treating Melanoma Prior Immune Checkpoint Inhibitor Therapy (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, University of California, San Francisco | Recruiting --> Active, not recruiting | Phase classification: P1/2 --> P1 | N=46 --> 6
    Enrollment closed • Phase classification • Enrollment change • Checkpoint inhibition • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • LAG3 (Lymphocyte Activating 3)
    |
    bavunalimab (XmAb22841) • izuralimab (XmAb23104)
    10ms
    A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3) (clinicaltrials.gov)
    P1, N=300, Active, not recruiting, Xencor, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Yervoy (ipilimumab) • izuralimab (XmAb23104)
    1year
    A Study of XmAb23104 in People With Sarcoma (clinicaltrials.gov)
    P2, N=6, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=30 --> 6 | Trial completion date: Apr 2028 --> Apr 2025 | Trial primary completion date: Apr 2028 --> Apr 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    izuralimab (XmAb23104)
    1year
    Phase Ib/II Study of XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) combination in metastatic melanoma refractory to prior immune checkpoint Inhibitor therapy with and without CNS disease (SITC 2023)
    1. At the time of this abstract submission, Cohort 1 of dose escalation has begun with the first few patients still within the DLT observation window.
    P1/2 data • Checkpoint inhibition • Metastases
    |
    PD-1 (Programmed cell death 1) • LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • ICOS (Inducible T Cell Costimulator)
    |
    bavunalimab (XmAb22841) • izuralimab (XmAb23104)
    over1year
    A Study of XmAb23104 in People With Sarcoma (clinicaltrials.gov)
    P2, N=30, Recruiting, Memorial Sloan Kettering Cancer Center
    New P2 trial • Metastases
    |
    izuralimab (XmAb23104)
    over1year
    Phase Ib/II study of XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) combination in metastatic melanoma refractory to prior immune checkpoint inhibitor therapy with and without CNS disease. (ASCO 2023)
    At the time of this abstract submission, Cohort 1 of dose escalation has begun with the first few patients still within the DLT observation window. Clinical trial information: NCT05695898.
    P1/2 data • Checkpoint inhibition • Metastases
    |
    PD-1 (Programmed cell death 1) • LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • ICOS (Inducible T Cell Costimulator)
    |
    bavunalimab (XmAb22841) • izuralimab (XmAb23104)
    over1year
    A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3) (clinicaltrials.gov)
    P1, N=300, Recruiting, Xencor, Inc. | Trial completion date: Dec 2024 --> Sep 2025 | Trial primary completion date: Jul 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Yervoy (ipilimumab) • izuralimab (XmAb23104)
    almost2years
    XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) in Treating Melanoma Prior Immune Checkpoint Inhibitor Therapy (clinicaltrials.gov)
    P1/2, N=46, Recruiting, University of California, San Francisco | Not yet recruiting --> Recruiting
    Enrollment open • Checkpoint inhibition • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • LAG3 (Lymphocyte Activating 3)
    |
    bavunalimab (XmAb22841) • izuralimab (XmAb23104)
    almost2years
    XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) in Treating Melanoma Prior Immune Checkpoint Inhibitor Therapy (clinicaltrials.gov)
    P1/2, N=46, Not yet recruiting, University of California, San Francisco
    New P1/2 trial • Checkpoint inhibition • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • LAG3 (Lymphocyte Activating 3)
    |
    bavunalimab (XmAb22841) • izuralimab (XmAb23104)
    over2years
    A phase 1 multiple-ascending dose study to evaluate the safety and tolerability of XmAb23104 (PD-1 x ICOS) in subjects with selected advanced solid tumors (DUET-3). (ASCO 2022)
    A minimum 6-week washout from prior pembrolizumab was required. The dose escalation part of this study indicates XmAb23104 was generally well tolerated at doses up to 15 mg/kg and has shown clinical activity in subjects with advanced solid tumors. CTLA4 blockade has been found to increase the frequency of ICOS-expressing T cells in prostate cancer, bladder cancer, melanoma, and hepatocellular cancer (Chen, 2009; Liakou, 2008; Wei, 2017) and may be applicable to other immunogenic tumor types. XmAb23104 is currently being studied alone or in combination with ipilimumab in expansion in non-squamous non-small cell lung carcinoma, melanoma, CRC, undifferentiated pleomorphic sarcoma, HNSCC, and RCC.
    Clinical • P1 data
    |
    MSI (Microsatellite instability) • PD-1 (Programmed cell death 1) • ICOS (Inducible T Cell Costimulator)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • izuralimab (XmAb23104)
    3years
    A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3) (clinicaltrials.gov)
    P1, N=234, Recruiting, Xencor, Inc. | Trial completion date: Mar 2025 --> Dec 2024 | Trial primary completion date: Sep 2024 --> Jul 2023
    Clinical • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Yervoy (ipilimumab) • izuralimab (XmAb23104)
    almost4years
    A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3) (clinicaltrials.gov)
    P1, N=234, Recruiting, Xencor, Inc. | N=164 --> 234
    Clinical • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Yervoy (ipilimumab) • izuralimab (XmAb23104)