RecruitingPhase 1NCT06632236

5G-EMERALD: Amivantamab in Malignant Brain Tumours

5G-EMERALD: A Phase 1 Trial of Amivantamab in High Grade Malignant Brain Tumours Within the 5G Platform

Sponsor

Institute of Cancer Research, United Kingdom

Enrollment

12 participants

Start Date

Oct 9, 2024

Study Type

INTERVENTIONAL

Conditions

Glioblastoma Multiforme (GBM)Malignant Primary Gliomas Glioblastoma Multiform (Grade IV Astrocytoma)Diffuse Hemispheric Glioma, H3 G34-Mutant

Summary

The purpose of this clinical trial is to evaluate the safety and tolerability of amivantamab and to determine the preliminary antitumour activity of amivantamab administered at the recommended Phase 2 dose (RP2D). In the Phase 1b of this study a biomarker defined arm will be opened, initially in the relapsed GMB setting, enrolling 12 patients. These patients will be treated with amivantamab monotherapy. Amivantamab will be administered intravenously (IV) weekly for the first 4 weeks, then every 2 weeks thereafter until disease progression or unacceptable toxicity. The first dose will be given as a split infusion, 350 mg IV over 4 hours on cycle 1 day 1 and 1400 mg IV over 6 hours on cycle 1 day 2. Subsequent infusions are given at a dose of 1750 mg IV over 2-5 hours in cycle 1 and between 2-3 hours from cycle 2 onwards if the first dose was well-tolerated with no significant toxicity. Progression to Phase 2 is dependent on emergent data and funding.

Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study (5G-EMERALD) is testing a drug called amivantamab — an antibody that targets proteins called EGFR and MET on cancer cells — in people with advanced brain tumors, primarily glioblastoma (an aggressive brain cancer that has returned after standard treatment). **You may be eligible if...** - You are 16 years or older - You have confirmed Grade 4 glioblastoma or certain other high-grade brain tumors - Your tumor has returned after standard surgery and chemo-radiation, or you have completed initial treatment with minimal remaining disease - Your neurological status is stable and your overall health is good **You may NOT be eligible if...** - You have tumor spread to the brainstem or spinal cord (leptomeningeal disease) - You have received prior EGFR-targeted therapy or immune checkpoint inhibitors - You have active hepatitis B, hepatitis C, or HIV - You have significant heart problems (recent heart attack, stroke, clots, or heart failure) - You have serious lung disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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