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Phase 2 Study of Sym004 for Adult Patients With Recurrent Glioblastoma

NCT02540161 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2020-08-05

Study results available
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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.

Conditions

  • Malignant Glioma

Interventions

DRUG

Sym004 - 18 mg/kg

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

DRUG

Sym004 - 24 mg/kg

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

Sponsors & Collaborators

  • Symphogen A/S

    collaborator INDUSTRY

  • Annick Desjardins

    lead OTHER

Principal Investigators

  • Annick Desjardins, MD, FRCPC · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2019-07-10
Completion
2020-04-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02540161 on ClinicalTrials.gov