PHASE 1/2 STUDY OF BLU-451 IN CANCERS WITH EGFR EXON20 MUTATIONS

• Research type

  Research Study

• Full title

  PHASE 1/2 STUDY OF BLU-451 IN ADVANCED CANCERS WITH EGFR EXON20 INSERTION MUTATIONS

• IRAS ID

  1007415

• Contact name

  Tanya Green

• Contact email

  tgreen@blueprintmedicines.com

• Sponsor organisation

  Blueprint Medicines Corporation

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT05241873

• Research summary

  Cancer is a disease in which cells in the body grow out of control. When cancer starts in the lungs, it is called lung cancer. Non-Small Cell Lung Cancer (NSCLC) is a type of lung cancer that is named for the kind of cells found in the tumour. When cancer cells spread from one organ to another, they are called metastases. A mutation is the way in which genes change and produce permanent differences. Epidermal growth factor receptor (EGFR) gene provides instructions for making EGFR protein, which is found on the surface of cells to which epidermal growth factor (EGF) binds. Mutations in the EGFR gene can lead to excess growth of cells and cancer.

  BLU-451 is an experimental drug, which is a highly potent, brain-penetrant inhibitor of EGFR mutations, including EGFR exon 20 insertions and other EGFR mutations which is developed to treat metastatic EGFR-mutant NSCLC.
  
  This phase 1/2 open-label study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of BLU-451.

  Global Phase 1 portion of the study will evaluate the different doses and regimes of BLU-451 to determine the recommended phase 2 dose (RP2D). Phase 2 portion will further evaluate the efficacy and safety of BLU-451 monotherapy in patients with NSCLC at the recommended Phase 2 dose established in Phase 1.

  Contrast-enhanced Computer Tomography and Magnetic Resonance Imaging will be used throughout the study to monitor the cancer status of the participants. Multi Gated Acquisition and Echocardiogram) can be used to monitor cardiac safety (left ventricular ejection fraction).
  The expected duration of this research study is approximately 42 months. The study is divided into three periods: a Screening period, a study treatment period, and a Follow-up period. It is expected that patients will remain on the study for an average of 12 months in phase 1, and 18 months in phase 2. However, no maximum study treatment duration is set.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  23/NW/0240

• Date of REC Opinion

  12 Dec 2023

• REC opinion

  Further Information Favourable Opinion