5G-EMERALD: Amivantamab in Malignant Brain Tumours

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.

NCT Number	NCT06632236
Lead Sponsor	Institute of Cancer Research, United Kingdom Collaborators: Royal Marsden NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Janssen Pharmaceutica N.V., Belgium, Cancer Research UK, Minderoo Foundation, University of Cambridge
Conditions	Malignant Primary Gliomas, Glioblastoma Multiform (Grade IV Astrocytoma), Diffuse Hemispheric Glioma, H3 G34-Mutant, Glioblastoma Multiforme (GBM)
Enrollment	12 participants
Start Date	2024-10-09
Primary Completion	2026-03-05 (estimated)
Study Completion	2027-03-05 (estimated)
Updated on ClinicalTrials.gov	2025-04-25