Clinical Trials /

Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma

NCT03296696

Description:

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).

Related Conditions:
  • Glioblastoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma
  • Official Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: 20160132
  • SECONDARY ID: 2017-001658-32
  • NCT ID: NCT03296696

Conditions

  • Glioblastoma

Interventions

DrugSynonymsArms
AMG 596Dose exploration

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Dose explorationExperimentalDose exploration of the intervention, AMG 596
  • AMG 596
Dose expansionExperimentalDose expansion of the intervention, AMG 596
  • AMG 596

Eligibility Criteria

        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.
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of subject with treatment-emergent adverse events
Time Frame:12 month
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response (OR) as per modified RANO
Time Frame:12 month
Safety Issue:
Description:Objective response (OR) as per modified RANO (Response Assessment in Neuro-Oncology Criteria).
Measure:Area under the concentration-time curve (AUC) for serum AMG 596
Time Frame:cycle length up to 6 weeks
Safety Issue:
Description:
Measure:Volume of distribution for serum AMG 596
Time Frame:cycle length up to 6 weeks
Safety Issue:
Description:
Measure:Average steady-state concentration (Css) for serum AMG 596
Time Frame:cycle length up to 6 weeks
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Amgen

Trial Keywords

  • Phase 1
  • EGFRvIII-positive glioblastoma
  • safety and tolerability
  • AMG 596

Last Updated

October 19, 2017