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Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma

NCT03296696 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-10-29

Study results available
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Summary

This is a Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 monotherapy or in combination with AMG 404 in Subjects with Glioblastoma or Malignant Glioma 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 or malignant glioma. 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).

Conditions

  • Glioblastoma or Malignant Glioma

Interventions

DRUG

AMG 596

Drug

DRUG

AMG 404

Drug

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-18
Primary Completion
2021-07-01
Completion
2021-08-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT03296696 on ClinicalTrials.gov