Phase 1b Study of Amivantamab for Patients with High Grade Malignant Brain Tumors Including Glioblastoma with EGFR Amplification

What this Trial Is About

Researchers are evaluating the safety and tolerability of amivantamab, an investigational drug, in patients with high grade malignant brain tumours such as glioblastoma. This Phase 1b trial focuses on a biomarker-defined group of patients whose tumours show EGFR amplification. The study aims to determine the preliminary anti-tumour activity of amivantamab administered at the recommended Phase 2 dose, with decisions guided by adaptive trial design and safety review committees. Amivantamab will be given by intravenous infusion weekly for the first 4 weeks, then every 2 weeks thereafter until the disease progresses or unacceptable side effects occur. The initial dose is split over two days, with subsequent doses given over 2 to 5 hours initially and shorter infusions if well tolerated. This Phase 1b biomarker arm will enroll 12 patients with relapsed glioblastoma to assess treatment effects. Participants will undergo regular monitoring including whole genome and transcriptome data collection as part of the Minderoo Precision Brain Tumour Programme. Safety and tumour response will be closely assessed through clinical evaluations and imaging over an 18-month period. The main outcomes measured are safety, tolerability, and preliminary anti-tumour activity, with additional analysis of molecular markers related to treatment response.

5G-EMERALD: Amivantamab in Malignant Brain Tumours