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Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Sym004 Doses Versus Investigator's Choice (Best Supportive Care, Capecitabine, 5-FU) in Subjects With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies

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Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Sym004 Doses Versus Investigator's Choice (Best Supportive Care, Capecitabine, 5-FU) in Subjects With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Futuximab/modotuximab (Primary) ; Capecitabine; Fluorouracil
  • Indications Colorectal cancer
  • Focus Proof of concept; Therapeutic Use
  • Sponsors EMD Serono; Merck KGaA; Symphogen

    • Most Recent Events

    • 19 Jan 2019 Results establishing a popPK model for Sym004 using data from 4 trials (Sym004-01, Sym004-02, Sym004-05 and Sym004-06) presented at the 2019 Gastrointestinal Cancers Symposium
    • 12 Sep 2017 Results presented at the 42nd European Society for Medical Oncology Congress
    • 12 Sep 2017 Results (n=193) assessing efficacy of futuximab versus best supportive care or capecitabine or 5-fluorouracil in patients with metastatic colorectal cancer and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies, were presented at the 42nd European Society for Medical Oncology Congress.

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