5G Master and 5G-EMERALD

• Research type

  Research Study

• Full title

  Minderoo 5G: A Next Generation AGile Genomically Guided Glioma Modular Platform for proof-of-concept molecular hypothesis testing in patients with high grade malignant brain tumours 5G-EMERALD: A Phase 1 trial of amivantamab in patients with high grade malignant brain tumours within the 5G platform

• IRAS ID

  1008334

• Contact name

  Juanita Lopez

• Contact email

  juanita.lopez@icr.ac.uk

• Sponsor organisation

  The Institute of Cancer Research

• Clinicaltrials.gov Identifier

  NCT06632236

• Research summary

  Precision medicine (also known as targeted medicine) is a modern approach to treating patients based upon the individual characteristics of their tumour cells. In this trial, every patient with glioblastoma (GBM), will have their tumour cells analysed by molecular profiling to identify their precise molecular flags. The results of these analyses allow the enrolment of patients with a particular flag/flags onto a matched novel drug or combination that has been specifically developed to target these aberrations. In other words, the choice of drug therapy (or treatment) is determined by the characteristics of each patient’s GBM.
  This trial uses this precision medicine approach to group patients according to the molecular characteristics of their GBM and test their matched drug in a three-phase approach. The first phase will establish the best dose to use (Phase 1a), the second phase will test if the drug shows clinical improvement (Phase 1b) and the third phase will assess the effectiveness of the drug (Phase 2).
  The 5G-EMERALD clinical study will investigate an experimental medication called amivantamab. This is the first time that this drug is given to patients with brain cancer. We want to find out if Amivantamab works for brain cancers that have a molecular flag named EGFR amplification (made in higher-than-normal amounts). EGFR is involved in cell signalling pathways that control cell division and survival. Sometimes, changes in the EGFR gene cause EGFR proteins to be made in above normal levels in some types of cancer cells. Amivantamab binds to EGFR, reducing its excessive amount in cancer cells.

• REC name

  London - Central Research Ethics Committee

• REC reference

  24/LO/0316

• Date of REC Opinion

  3 Jun 2024

• REC opinion

  Further Information Favourable Opinion