Phase 2 Study of Sym004 for Adult Patients With Recurrent Glioblastoma

Completed · Phase 2

Conditions studied: Malignant Glioma

In brief

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.

Key facts

Study ID

NCT02540161

Run by

Annick Desjardins

People needed

43

Starts

2016-02-01

Expected to finish

2020-04-27

Last updated by the study team

2020-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically confirmed diagnosis of World Health Organization (WHO) grade 4 malignant glioma and radiographic evidence of recurrence or disease progression (as defined by the Response Assessment in Neuro-Oncology (RANO) criteria as a greater than 25% increase in the largest bi-dimensional product of enhancement or a new enhancing lesion, or a significant increase in T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) abnormality without another co-morbid cause);
• Age ≥ 18 years;
• Karnofsky Performance Status ≥ 70%;
• No more than 3 prior progressions;
• Cohort 1 only: Non-bevacizumab failure, i.e. either no prior bevacizumab or bevacizumab stable/responder, which is defined as stable within 6 months of prior treatment with bevacizumab without experiencing a bevacizumab adverse event of special interest (AESI) while on a bevacizumab-containing regimen, such as:
• ≥ grade 3 hypertension not controlled by medication, hypertensive crisis, or hypertensive encephalopathy
• ≥ grade 3 proteinuria that does not resolve or nephrotic syndrome
• Any grade GI perforation
• ≥ grade 3 infusion-related reaction
• ≥ grade 3 woundhealing complications
• ≥ grade 3 hemorrhage or any grade central nervous system (CNS) hemorrhage or ≥ grade 2 hemoptysis
• Any grade arterial thromboembolic event (e.g. myocardial infarction or cerebral infarction) or ≥ grade 3 venous thromboembolic event
• Any grade posterior reversible encephalopathy syndrome (PRES)
• ≥ grade 3 congestive heart failure
• ≥ grade 2 non-gastrointestinal (GI) abscesses and fistulae;
• Cohort 2 only: Prior progression on a bevacizumab-containing regimen (defined as having progressed/grown through bevacizumab by RANO criteria within 2 months of prior bevacizumab treatment);
• Pathology consistent with Epidermal Growth Factor Receptor (EGFR)-amplification of tumor (i.e. greater than 15% of cells exhibiting > 5 copies of EGFR loci); archival tissue may be tested for EGFR status in a separate consent;
• Absolute Neutrophil Count (ANC) ≥ 1,000 cells/µl, platelets ≥ 100,000 cells/µl, hemoglobin ≥ 9 g/dL;
• Adequate renal function as indicated by the following:
• Serum creatinine < 1.25 times upper limit of normal or calculated creatinine clearance ≥ 50 ml/min;
• Urine dipstick for proteinuria < 2+ unless a 24-hour urine protein <1 g of protein is demonstrated;
• Adequate liver function as indicated by the following:
• Total bilirubin ≤ 1.6 mg/dL;
• Aspartate transaminase/alanine transaminase (AST/ALT) ≤ 2.5 x the upper limit of normal (ULN);
• Magnesium ≥ 0.9 mg/dL;

You may not qualify if…

• Pregnancy or breastfeeding;
• Prior treatment with EGFR-targeted therapy, including, but not limited to, the following examples: Gilotrif® (afatinib),Tarceva® (erlotinib), Erbitux® (cetuximab), Iressa™ (gefitinib), Vectibix® (panitumumab), Caprelsa® (vandetanib), Tykerb® (lapatinib), CDX110, D2C7-immunotoxin;
• Active infection requiring intravenous antibiotics within 7 days before enrollment;
• Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin;
• Less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation;
• Treated with immunotherapeutic agents, vaccines, or Mab therapy within 4 weeks before enrollment, unless the patient has recovered from the expected toxic effects of such therapy
• Treated with alkylating agents within 4 weeks (6 weeks for nitrosoureas) before enrollment or treated within 1 week before enrollment with daily or metronomic chemotherapy, unless the patient has recovered from the expected toxic effects of such therapy to their baseline or to grade 1;
• Prior treatment (non-alkylating agents) within 2 weeks before enrollment, unless the patient has recovered from the expected toxic effects of such therapy;
• Known hypersensitivity reactions to any of the components of Sym004;
• Known current drug abuse or alcohol abuse;
• Known Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C infection. Testing is not required as part of this study.

Where it is running

• The Preston Robert Tisch Brain Tumor Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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