A Phase I/IIa trial of BT1718 in patients with advanced solid tumours

• Research type

  Research Study

• Full title

  A Cancer Research UK Phase I/IIa trial of BT1718, (A Bicycle drug conjugate), given intravenously in patients with advanced solid tumours.

• IRAS ID

  228376

• Contact name

  Udai Banerji

• Contact email

  udai.Banerji@icr.ac.uk

• Sponsor organisation

  Cancer Research UK, Centre for Drug Development

• Eudract number

  2016-004633-24

• Duration of Study in the UK

  4 years, 0 months, 31 days

• Research summary

  Research summary
  In some cancer cells the protein called ‘membrane type 1 metalloproteinase’ (MT1-MMP) is produced in higher quantities and is linked to poor prognosis. This clinical study is looking at a drug called BT1718 which is designed to recognise and attach to the MT1-MMP protein found on cancer cells. Once attached to MT1-MMP, a segment of BT1718 (cytotoxic agent DM1) is taken into the cancer cell causing cell death.

  This is a first in human clinical study which has two phases.

  A ‘dose escalation’ phase where groups of patients will receive increasing doses of BT1718 to find a safe dose that best targets the cancer cells.

  An ‘expansion phase’ where larger groups of patients will receive the selected dose of BT1718 to allow us to find out more about how the drug is working.

  In the dose escalation phase it is expected that approximately 40-50 patients with advanced solid tumours will be entered in the study.

  In the expansion phase it is proposed that approximately 60-70 patients with either Triple Negative Breast Cancer (TNBC), Non-Small Cell Lung Cancer (NSCLC) or Sarcoma will be entered in the study, as these tumour types are commonly known to overexpress MT1-MMP.

  The main aims of this study are to find out:
  - The maximum dose that can be given safely to patients
  - More about the potential side effects of BT1718 and how they can be managed
  - What happens to BT1718 when inside the body

  This study will be conducted at up to five NHS sites across the UK.

  This study is sponsored by Cancer Research UK (CRUK) and BT1718 is developed by Bicycle Therapeutics Ltd.

  Summary of Results

  A summary of results is available at https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-bt1718-for-advanced-cancer
  In the expansion phase (“Phase 2”), there were 2 groups: a Cohort of patients with Squamous Non-Small Cell Lung cancer (NSCLC) and a Basket Cohort of patients with advanced solid tumours.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  17/LO/1862

• Date of REC Opinion

  23 Nov 2017

• REC opinion

  Favourable Opinion