Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 100
Updated:4/6/2019
Start Date:April 18, 2018
End Date:April 1, 2021
Contact:Amgen Call Center
Email:medinfo@amgen.com
Phone:866-572-6436

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Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 in Subjects With Glioblastoma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)

This is a Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and
Pharmacodynamics of AMG 596 in Subjects with Glioblastoma Expressing Mutant Epidermal Growth
Factor Receptor Variant III (EGFRvIII). This is a first in human (FIH), open-label,
sequential-dose-escalation study in subjects with EGFRvIII-positive glioblastoma. This study
will enroll 2 groups of subjects according to disease stage, recurrent disease (Group 1) and
maintenance treatment after SoC in newly diagnosed disease (Group 2).


Inclusion Criteria

- Eastern Cooperative Oncology Group (ECOG, Appendix F) Performance Status of ≤ 1

- Life expectancy of at least 3 months, in the opinion of the investigator.

- Must have pathologically documented, and definitively diagnosed World Health
Organization (WHO) grade 4, glioblastoma

- Must have recurrent disease confirmed by MRI (Group 1) or completed SoC therapy such
as surgery with adjuvant radiochemotherapy with or without maintenance temozolomide
according to local standards for newly diagnosed disease (Group 2)

- Renal function and Hepatic function

Exclusion Criteria

- History or evidence of central nervous system bleeding as defined by stroke or
intraocular bleed (including embolic stroke) not associated with any antitumor surgery
within 6 months before enrolment

- Known hypersensitivity to immunoglobulins or to any other component of the IP
formulation

- Infection requiring intravenous antibiotics that was completed < 1 week of study
enrollment (day 1) with the exemption of prophylactic antibiotics for long line
insertion or biopsy

- Unresolved toxicities from prior antitumor therapy, defined as not having resolved to
CTCAE, version 4.0 grade 1 (with the exception of myelosuppression, e.g., neutropenia,
anemia, thrombocytopenia), or to levels dictated in the eligibility criteria with the
exception of alopecia or toxicities from prior antitumor therapy that are considered
irreversible (defined as having been present and stable for > 2 months) which may be
allowed if they are not otherwise described in the exclusion criteria AND there is
agreement to allow by both the investigator and sponsor

- Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, or
investigational agent) within 14 days (Group 2 subjects) or 5 half-lives (whichever is
longer: for Group 1 subjects) of day 1.
We found this trial at
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St Leonards, New South Wales 2065
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St Leonards,
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