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    DRUG:

    cergutuzumab amunaleukin (RG7813)

    i
    Other names: RG7813, RO-6895882, RO6895882, RG-7813, CEA-IL2v, CEA IL2v FP, aCEA-IL2v FP
    Associations

    News

    Trials
    Company:
    Roche
    Drug class:
    Immunostimulant, IL-2 stimulant, CEACAM5 inhibitor
    Related drugs:
    Associations

    News

    Trials
    18d
    Biomarkers of activity from a phase I study of cergutuzumab amunaleukin in patients with advanced solid tumors. (PubMed, J Immunother Cancer)
    CA-induced immune pharmacodynamic effects in peripheral blood and in the tumor microenvironment without preferential Treg cell activation in patients with metastatic/unresectable CEA+ solid tumors.
    P1 data • Journal • PD(L)-1 Biomarker • First-in-human
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • TNFA (Tumor Necrosis Factor-Alpha) • CEACAM5 (CEA Cell Adhesion Molecule 5) • IL2RA (Interleukin 2 receptor, alpha) • IL2 (Interleukin 2) • CD14 (CD14 Molecule)
    |
    cergutuzumab amunaleukin (RG7813)
    3ms
    Cergutuzumab Amunaleukin in Combination with Atezolizumab in Patients with Carcinoembryonic Antigen-Positive Advanced/Metastatic Solid Tumors. (PubMed, Clin Cancer Res)
    The safety profile of this combination was manageable. Prominent pharmacodynamic effects were elucidated; antitumor activity was limited.
    Journal • PD(L)-1 Biomarker
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5) • IL2RA (Interleukin 2 receptor, alpha) • IL2 (Interleukin 2) • CRP (C-reactive protein)
    |
    Tecentriq (atezolizumab) • Gazyva (obinutuzumab) • cergutuzumab amunaleukin (RG7813)
    almost2years
    Obinutuzumab Pretreatment as a Novel Approach to Mitigate Formation of Anti-Drug Antibodies Against Cergutuzumab Amunaleukin in Patients with Solid Tumors. (PubMed, Clin Cancer Res)
    These preliminary findings suggest that obinutuzumab pretreatment before CEA-IL2v administration in patients with CEA+ solid tumors may be a feasible and potent ADA mitigation strategy, with an acceptable safety profile, supporting broader investigation of obinutuzumab pretreatment for ADA mitigation in other settings.
    Journal
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 positive
    |
    Tecentriq (atezolizumab) • Rituxan (rituximab) • Gazyva (obinutuzumab) • cergutuzumab amunaleukin (RG7813)
    6years
    A Study of Intravenous (IV) Cergutuzumab Amunaleukin and Atezolizumab in Combination in Participants With Locally Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov)
    P1b, N=70, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed
    Clinical • Trial completion
    |
    CD8 (cluster of differentiation 8) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression
    |
    Tecentriq (atezolizumab) • cergutuzumab amunaleukin (RG7813)
    6years
    Prediction of the optimal dosing regimen using a mathematical model of tumour uptake for immunocytokine-based cancer immunotherapy. (PubMed, Clin Cancer Res)
    The model presented here allows simulation of individualized treatment plans for optimal dosing and scheduling of immunocytokines for anti-cancer immunotherapy.
    Journal
    |
    IL2RA (Interleukin 2 receptor, alpha)
    |
    cergutuzumab amunaleukin (RG7813)
    over6years
    A Study of Intravenous (IV) Cergutuzumab Amunaleukin and Atezolizumab in Combination in Participants With Locally Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov)
    P1b, N=70, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting | Trial completion date: May 2019 --> Oct 2019 | Trial primary completion date: May 2019 --> Oct 2019
    Clinical • Enrollment closed • Trial completion date • Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression
    |
    Tecentriq (atezolizumab) • cergutuzumab amunaleukin (RG7813)
    7years
    A Study of Intravenous (IV) Cergutuzumab Amunaleukin and Atezolizumab in Combination in Participants With Locally Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov)
    P1b, N=75, Recruiting, Hoffmann-La Roche | Trial completion date: Dec 2018 --> Apr 2019 | Trial primary completion date: Dec 2018 --> Apr 2019
    Clinical • Trial completion date • Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression
    |
    Tecentriq (atezolizumab) • cergutuzumab amunaleukin (RG7813)