Malignant Glioma Clinical Trial
Official title:
Phase 2 Study of Sym004 for Adult Patients With Recurrent Glioblastoma
The purpose of this study is to assess the activity of Sym004, a recombinant antibody mixture that specifically binds to EGFR, in patients diagnosed with recurrent glioblastoma whose tumor is EGFR amplified. This is a phase 2 study that will accrue patients with WHO grade IV recurrent malignant glioma (glioblastoma or gliosarcoma) in two cohorts to assess the efficacy of Sym004.
The purpose of this study is to assess the activity of Sym004, a recombinant antibody mixture
that specifically binds to EGFR, in patients diagnosed with recurrent glioblastoma whose
tumor is EGFR amplified. The primary objective is to assess the activity of Sym004 in
patients with recurrent glioblastoma that are either non-bevacizumab failures (Cohort 1) or
who have previously failed bevacizumab (Cohort 2), in terms of 6-month progression-free
survival (PFS6). Secondary objectives include: 1. Determine the safety of Sym004 in recurrent
glioblastoma (GBM) patients; 2. Estimate response rate (RR) within the two cohorts of
recurrent GBM patients; 3. Describe overall survival (OS) within the two cohorts of recurrent
GBM patients; 4. Describe overall median progress free survival (PFS) within the two cohorts
of recurrent GBM patients.
This is a phase 2 study that will accrue patients with WHO grade IV recurrent malignant
glioma (glioblastoma or gliosarcoma) in two cohorts to assess the efficacy of Sym004. Both
cohorts will accrue simultaneously, with 36 subjects in Cohort 1 and 25 subjects in Cohort 2
at a dose of 18 mg/kg Sym004 given intravenously every 2 weeks. A treatment cycle will be 4
weeks.
Twenty-five subjects have been treated at the 18 mg/kg dose of Sym004. Beginning in August
2017, the dose of Sym004 will be increased to 24 mg/kg. Sixty-five additional subjects (36 in
Cohort 1 and 29 in Cohort 2) will be treated at the new dose level.
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