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    DRUG:

    ficlatuzumab (AV-299)

    i
    Other names: AV-299, SCH 900105, AV299 , Ficla, SCH-900105, AV 299, SCH900105
    Company:
    Biodesix, LG Chem, Xoma
    Drug class:
    c-MET inhibitor, Hepatocyte growth factor inhibitor
    Related drugs:
    almost2years
    FIERCE-HN: A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=410, Recruiting, AVEO Pharmaceuticals, Inc.
    Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    Erbitux (cetuximab) • ficlatuzumab (AV-299)
    2years
    FIERCE-HN: A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=410, Recruiting, AVEO Pharmaceuticals, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    Erbitux (cetuximab) • ficlatuzumab (AV-299)
    2years
    FIERCE-HN: A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=410, Not yet recruiting, AVEO Pharmaceuticals, Inc.
    New P3 trial • Combination therapy • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    Erbitux (cetuximab) • ficlatuzumab (AV-299)
    over2years
    P30CA023074: Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=78, Completed, University of Arizona | N=60 --> 78
    Enrollment change
    |
    CD27 (CD27 Molecule)
    |
    Erbitux (cetuximab) • ficlatuzumab (AV-299)
    over2years
    Phase Ib and Expansion Study of Gemcitabine, Nab-Paclitaxel, and Ficlatuzumab in Patients With Metastatic Pancreatic Cancer. (PubMed, Oncologist)
    In this phase Ib trial, ficlatuzumab, gemcitabine, and albumin-bound paclitaxel were associated with durable treatment responses and increased rates of hypoalbuminemia and edema.
    P1 data • Clinical Trial,Phase I • Journal • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    gemcitabine • albumin-bound paclitaxel • ficlatuzumab (AV-299)
    over2years
    Randomized Phase II Trial of Ficlatuzumab With or Without Cetuximab in Pan-Refractory, Recurrent/Metastatic Head and Neck Cancer. (PubMed, J Clin Oncol)
    The ficlatuzumab-cetuximab arm met significance criteria for PFS and warrants phase III development. HPV-negative HNSCC merits consideration as a selection criterion.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    Erbitux (cetuximab) • ficlatuzumab (AV-299)
    3years
    P30CA023074: Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2; Active, not recruiting --> Completed
    Trial completion
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog) • IL6 (Interleukin 6) • CD27 (CD27 Molecule)
    |
    EGFR mutation • PIK3CA mutation
    |
    VeriStrat®
    |
    Erbitux (cetuximab) • ficlatuzumab (AV-299)
    over3years
    P30CA023074: Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=74, Active, not recruiting, University of Arizona | Trial completion date: Dec 2021 --> May 2022 | Trial primary completion date: Dec 2021 --> May 2022
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog) • IL6 (Interleukin 6) • CD27 (CD27 Molecule)
    |
    EGFR mutation • PIK3CA mutation
    |
    Erbitux (cetuximab) • ficlatuzumab (AV-299)
    4years
    Inhibition of MET Signaling with Ficlatuzumab in Combination with Chemotherapy in Refractory AML: Clinical Outcomes and High-Dimensional Analysis. (PubMed, Blood Cancer Discov)
    The ficlatuzumab and cytarabine combination is well-tolerated with favorable efficacy. High-dimensional analyses at single-cell resolution represent promising approaches for identifying biomarkers of response and mechanisms of resistance in prospective clinical studies.
    Clinical • Clinical data • Journal • Combination therapy
    |
    HGF (Hepatocyte growth factor)
    |
    cytarabine • ficlatuzumab (AV-299)
    over4years
    P30CA023074: Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=74, Active, not recruiting, University of Arizona | Trial completion date: May 2021 --> Dec 2021 | Trial primary completion date: May 2021 --> Dec 2021
    Clinical • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog) • IL6 (Interleukin 6) • CD27 (CD27 Molecule)
    |
    EGFR mutation • PIK3CA mutation
    |
    Erbitux (cetuximab) • ficlatuzumab (AV-299)
    almost5years
    P30CA023074: Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=74, Active, not recruiting, University of Arizona | Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> May 2021 | Trial primary completion date: Dec 2020 --> May 2021
    Clinical • Enrollment closed • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog) • IL6 (Interleukin 6) • CD27 (CD27 Molecule)
    |
    EGFR mutation • PIK3CA mutation
    |
    Erbitux (cetuximab) • ficlatuzumab (AV-299)
    over5years
    Phase I Study of Ficlatuzumab and Cetuximab in Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Cancer. (PubMed, Cancers (Basel))
    An increase in peripheral T cells, particularly the CD8 subset, was associated with treatment response whereas progression was associated with expansion of a distinct myeloid population. This well-tolerated combination demonstrated promising activity in cetuximab-resistant, advanced HNSCC.
    P1 data • Journal
    |
    CD8 (cluster of differentiation 8)
    |
    Erbitux (cetuximab) • ficlatuzumab (AV-299)