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    DRUG:

    vudalimab (XmAb717)

    i
    Other names: XmAb717, XmAb 20717, XmAb20717
    Company:
    Xencor
    Drug class:
    PD1 inhibitor, CTLA4 inhibitor
    Related drugs:
    2ms
    XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=85, Recruiting, Xencor, Inc. | Trial completion date: Jun 2024 --> Sep 2025 | Trial primary completion date: Jun 2023 --> Mar 2025
    Trial completion date • Trial primary completion date • Combination therapy • Tumor mutational burden • Metastases
    |
    TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency)
    |
    TMB-H • MSI-H/dMMR
    |
    Lynparza (olaparib) • carboplatin • docetaxel • cabazitaxel • vudalimab (XmAb717)
    3ms
    A Phase II Clinical Trial to Evaluate Safety and Efficacy of XmAb20717 in Advanced Rare Cancers (clinicaltrials.gov)
    P2, N=140, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    vudalimab (XmAb717)
    3ms
    Regorafenib and XmAb20717 in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy (RX-CROME) (clinicaltrials.gov)
    P2; N=16 --> 0 | Trial completion date: Dec 2026 --> Feb 2024 | Initiation date: Nov 2024 --> May 2023 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2024 --> Feb 2024
    Trial completion date • Trial primary completion date • Enrollment change • Trial withdrawal • Trial initiation date
    |
    Signatera™
    |
    Stivarga (regorafenib) • vudalimab (XmAb717)
    3ms
    XmAb20717 in Advanced Biliary Tract Cancers (clinicaltrials.gov)
    P2, N=27, Active, not recruiting, Abramson Cancer Center at Penn Medicine | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    IDH1 mutation • FGFR2 mutation • FGFR2 fusion • NTRK fusion
    |
    vudalimab (XmAb717)
    4ms
    Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC (clinicaltrials.gov)
    P1/2, N=168, Recruiting, Xencor, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • carboplatin • pemetrexed • vudalimab (XmAb717)
    5ms
    Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC (clinicaltrials.gov)
    P1/2, N=168, Not yet recruiting, Xencor, Inc.
    New P1/2 trial
    |
    Keytruda (pembrolizumab) • carboplatin • pemetrexed • vudalimab (XmAb717)
    5ms
    Regorafenib and XmAb20717 in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy (RX-CROME) (clinicaltrials.gov)
    P2; Initiation date: Nov 2023 --> Nov 2024
    Trial initiation date
    |
    Signatera™
    |
    Stivarga (regorafenib) • vudalimab (XmAb717)
    7ms
    A Study of XmAb20717 (Vudalimab)in Patients With Selected Advanced Gynecologic and Genitourinary Malignancies (clinicaltrials.gov)
    P2, N=150, Recruiting, Xencor, Inc. | Trial completion date: Aug 2023 --> May 2025 | Trial primary completion date: Jul 2023 --> Mar 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    vudalimab (XmAb717)
    10ms
    Vudalimab (XmAb20717) in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Emory University | Initiation date: Jun 2023 --> Oct 2023
    Trial initiation date • Combination therapy • Metastases
    |
    docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • vudalimab (XmAb717)
    11ms
    Regorafenib and XmAb20717 in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy (RX-CROME) (clinicaltrials.gov)
    P2; N=16; Not yet recruiting; Sponsor:M.D. Anderson Cancer Center
    New P2 trial
    |
    Signatera™
    |
    Stivarga (regorafenib) • vudalimab (XmAb717)
    12ms
    Vudalimab (XmAb20717) in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Emory University | Initiation date: Mar 2023 --> Jun 2023
    Trial initiation date • Combination therapy • Metastases
    |
    docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • vudalimab (XmAb717)
    over1year
    DUET-2: A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=150, Completed, Xencor, Inc. | Active, not recruiting --> Completed | Trial primary completion date: Nov 2022 --> Jun 2022
    Trial completion • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 negative
    |
    vudalimab (XmAb717)
    over1year
    A Phase 2 study of vudalimab, a PD-1 x CTLA-4 bispecific antibody, plus chemotherapy or targeted therapy in patients with molecularly defined subtypes of metastatic castration-resistant prostate cancer (SITC 2022)
    Patients receive vudalimab 10 mg/kg intravenously every 2 weeks plus either carboplatin AUC 4/cabazitaxel 20 mg/m 2 (or docetaxel 60 mg/m 2 , if chemotherapy naïve) every 3 weeks (Cohorts 1, 2, 5; n=20 each) or olaparib 300 mg 2x/day (Cohort 3; n=20), or as monotherapy (Cohort 4; n=5). Preliminary safety and activity data will be presented. Trial Registration NCT05005728
    Clinical • P2 data • MSi-H Biomarker • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency) • CDK12 (Cyclin dependent kinase 12) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    MSI-H/dMMR • CDK12 mutation • PARP1 mutation
    |
    Lynparza (olaparib) • carboplatin • docetaxel • cabazitaxel • vudalimab (XmAb717)
    over1year
    Vudalimab for the Treatment of Locally Advanced or Metastatic Anaplastic Thyroid Cancer or Hurthle Cell Thyroid Cancer (clinicaltrials.gov)
    P2, N=54, Recruiting, Northwestern University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BRAF (B-raf proto-oncogene) • CD4 (CD4 Molecule)
    |
    BRAF V600E
    |
    vudalimab (XmAb717)
    over1year
    A Phase II Clinical Trial to Evaluate Safety and Efficacy of XmAb20717 in Advanced Rare Cancers (clinicaltrials.gov)
    P2, N=140, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting | Initiation date: May 2022 --> Aug 2022
    Enrollment open • Trial initiation date
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    vudalimab (XmAb717)
    almost2years
    DUET-2: A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=154, Active, not recruiting, Xencor, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Feb 2023 --> Nov 2022
    Enrollment closed • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 negative
    |
    vudalimab (XmAb717)
    almost2years
    Vudalimab for the Treatment of Locally Advanced or Metastatic Anaplastic Thyroid Cancer or Hurthle Cell Thyroid Cancer (clinicaltrials.gov)
    P2, N=54, Not yet recruiting, Northwestern University
    New P2 trial
    |
    BRAF (B-raf proto-oncogene) • CD4 (CD4 Molecule)
    |
    BRAF V600E
    |
    vudalimab (XmAb717)
    2years
    A phase 2, multicenter, parallel-group, open-label study of vudalimab (XmAb20717), a PD-1 x CTLA-4 bispecific antibody, alone or in combination with chemotherapy or targeted therapy in patients with molecularly defined subtypes of metastatic castration-resistant prostate cancer. (ASCO 2022)
    Cohorts 1, 2, and 5 (n = 20 each) also will receive carboplatin AUC 4 + cabazitaxel 20 mg/m2 (or docetaxel 60 mg/m2, if not received prior) every 3 weeks; Cohort 3 (n = 20) also will receive olaparib 300 mg 2x/day; and Cohort 4 (n = 5) will receive vudalimab monotherapy. Exploratory objectives include assessing pharmacodynamic activity in peripheral blood and tumor, and correlations of response with cohort-specific molecular tumor characteristics. Enrollment has been initiated.
    Clinical • P2 data • Combination therapy • MSi-H Biomarker • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency) • PD-1 (Programmed cell death 1) • CDK12 (Cyclin dependent kinase 12) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    MSI-H/dMMR • CDK12 mutation • PARP1 mutation
    |
    Lynparza (olaparib) • carboplatin • docetaxel • cabazitaxel • vudalimab (XmAb717)
    2years
    A Phase II Clinical Trial to Evaluate Safety and Efficacy of XmAb20717 in Advanced Rare Cancers (clinicaltrials.gov)
    P2, N=140, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    vudalimab (XmAb717)
    2years
    XmAb20717 in Advanced Biliary Tract Cancers (clinicaltrials.gov)
    P2, N=27, Recruiting, Abramson Cancer Center of the University of Pennsylvania | Not yet recruiting --> Recruiting
    Enrollment open
    |
    FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    IDH1 mutation • FGFR2 mutation • FGFR2 fusion • NTRK fusion
    |
    vudalimab (XmAb717)
    2years
    DUET-2: A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=154, Recruiting, Xencor, Inc. | Trial primary completion date: Apr 2022 --> Nov 2022
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 negative
    |
    vudalimab (XmAb717)
    2years
    XmAb20717 in Advanced Biliary Tract Cancers (clinicaltrials.gov)
    P2, N=27, Not yet recruiting, Abramson Cancer Center of the University of Pennsylvania
    New P2 trial
    |
    FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    IDH1 mutation • FGFR2 mutation • FGFR2 fusion • NTRK fusion
    |
    vudalimab (XmAb717)
    over2years
    XmAb®20717 Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=85, Recruiting, Xencor, Inc. | Trial completion date: Jun 2023 --> Jun 2024
    Trial completion date • Combination therapy
    |
    MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency)
    |
    MSI-H/dMMR
    |
    Lynparza (olaparib) • carboplatin • cabazitaxel • vudalimab (XmAb717)
    over2years
    XmAb®20717 Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=85, Recruiting, Xencor, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency)
    |
    MSI-H/dMMR
    |
    Lynparza (olaparib) • carboplatin • cabazitaxel • vudalimab (XmAb717)
    over2years
    Preliminary clinical experience with XmAb20717, a PD-1 x CTLA-4 bispecific antibody, in patients with advanced solid tumors (SITC 2021)
    These findings support further development of XmAb20717 in advanced solid tumors, including metastatic prostate cancer. Trial Registration NCT03517488
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD4 (CD4 Molecule)
    |
    vudalimab (XmAb717)
    over2years
    XmAb®20717 Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=85, Not yet recruiting, Xencor, Inc.
    Clinical • New P2 trial • Combination therapy
    |
    MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency)
    |
    MSI-H/dMMR
    |
    Lynparza (olaparib) • carboplatin • cabazitaxel • vudalimab (XmAb717)
    3years
    DUET-2: A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=154, Recruiting, Xencor, Inc. | Trial completion date: Mar 2021 --> Feb 2023 | Trial primary completion date: Dec 2020 --> Feb 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 negative
    |
    vudalimab (XmAb717)
    over3years
    [VIRTUAL] Preliminary safety, pharmacokinetics/pharmacodynamics, and antitumor activity of XmAb20717, a PD-1 x CTLA-4 bispecific antibody, in patients with advanced solid tumors (SITC 2020)
    Responses were observed only at 10 mg/kg and, within the 10 mg/kg group, appeared to correlate with higher peak serum concentration and area under the curve.View this table:View inline Conclusions XmAb20717 induced T-cell proliferation in peripheral blood consistent with dual-checkpoint blockade. Preliminary data indicate XmAb20717 was generally well-tolerated and associated with evidence of antitumor activity in CI-pretreated patients with various types of advanced solid tumors.
    Clinical • PK/PD data
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    vudalimab (XmAb717)
    over3years
    [VIRTUAL] Preliminary safety, pharmacokinetics/pharmacodynamics, and antitumor activity of XmAb20717, a PD-1 x CTLA-4 bispecific antibody, in patients with advanced solid tumors (SITC 2020)
    Responses were observed only at 10 mg/kg and, within the 10 mg/kg group, appeared to correlate with higher peak serum concentration and area under the curve.View this table:View inline Conclusions XmAb20717 induced T-cell proliferation in peripheral blood consistent with dual-checkpoint blockade. Preliminary data indicate XmAb20717 was generally well-tolerated and associated with evidence of antitumor activity in CI-pretreated patients with various types of advanced solid tumors.
    Clinical • PK/PD data
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    vudalimab (XmAb717)
    4years
    [VIRTUAL] Preliminary safety and pharmacodynamic (PD) activity of XmAb20717, a PD-1 x CTLA-4 bispecific antibody, in a phase I dose escalation study of patients with selected advanced solid tumors. (ASCO 2020)
    Responses were evaluated based on RECIST 1.1 criteria, and there was 1 CR reported (melanoma, progressed on prior pembrolizumab) at 10 mg/kg (highest dose level). XmAb20717 is generally safe and has demonstrated PD activity in heavily pretreated patients with selected advanced solid tumors. Dose escalation continues. Research Funding: Xencor, Inc.
    Clinical • P1 data • PK/PD data
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Keytruda (pembrolizumab) • vudalimab (XmAb717)
    4years
    DUET-2: A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=154, Recruiting, Xencor, Inc. | N=87 --> 154
    Clinical • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 negative
    |
    vudalimab (XmAb717)