At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 43 enrolled

Drug / intervention

Sym004 - 18 mg/kg +1 moredrug

Likely dose

Sym004 - 18 mg/kgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02540161

NCT02540161Phase 2Completed

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Phase 2 Study of Sym004 for Adult Patients With Recurrent Glioblastoma

Annick Desjardins·interventional·Posted Sep 3, 2015·Updated Aug 5, 2020

In Brief

A Phase 2 clinical trial evaluating Sym004 - 18 mg/kg and Sym004 - 24 mg/kg for Malignant Glioma. Completed, enrolled 43 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMalignant Glioma

CountriesUnited States

CollaboratorsSymphogen A/S

Timeline

Phase 2CompletedFinished

20162017201820192020202120222023202420252026

First PostedSep 2015

Enrollment StartFeb 2016

Primary CompletionJul 2019

Study CompletionApr 2020

TodayJul 2026

First PostedSep 3, 2015

Enrollment StartFeb 1, 2016

Primary CompletionJul 10, 2019

Study CompletionApr 27, 2020

TodayJul 2, 2026

Enrollment to primary: 3.4 yearsPosted 10.8 years ago

Interventions

Sym004 - 18 mg/kgdrug

Sym004 was dosed at 18 mg/kg intravenously every two weeks.

Sym004 - 24 mg/kgdrug

Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.