NCT03296696

Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma

Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 as Monotherapy and in Combination With AMG 404 in Subjects With Glioblastoma or Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	AMG 596	Drug
DRUG	AMG 404	Drug

Timeline

• Start date: 2018-04-18
• Primary completion: 2021-07-01
• Completion: 2021-08-28
• First posted: 2017-09-28
• Last updated: 2024-10-29
• Results posted: 2024-10-29

Locations

10 sites across 6 countries: United States, Australia, France, Germany, Netherlands, Spain

Regulatory

• FDA-regulated drug study