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5G-EMERALD: Amivantamab in Malignant Brain Tumours

Study acronym: 5G-EMERALD
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Mar 5, 2026 → Jul 1, 2027
See other at-risk trials from Institute of Cancer Research, United Kingdom

Record History

  1. Primary completion pushed from Mar 5, 2026 to Jul 1, 2027
    • Enrollment closed, study ongoing
    • Study completion pushed from Mar 5, 2027 to Jul 1, 2027
    • Site details revised at 2 of 2 sites
    v5
  2. Site details revised at 1 of 2 sitesv4
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 5, 2024 to Oct 9, 2024
    • Site details revised at 2 of 2 sites
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Malignant Primary Gliomas, Glioblastoma Multiform (Grade IV Astrocytoma), Diffuse Hemispheric Glioma, H3 G34-Mutant, Glioblastoma Multiforme (GBM)
Related terms Glioblastoma
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov