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izuralimab (XmAb23104)
i
Other names: XmAb23104, XmAb 23104, XmAb104
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News alerts, weekly reports and conference planners
Company:
Xencor
Drug class:
PD1 inhibitor, ICOS stimulant
Related drugs:
1m
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)
3ms
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)
5ms
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)
7ms
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)
11ms
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)
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. (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)
1year
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)
1year
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)
over1year
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)
2years
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)
over2years
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)
over3years
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)
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