A Phase I trial of CCT361814 in advanced cancer

• Research type

  Research Study

• Full title

  A Cancer Research UK Phase I, first in human clinical trial of CCT361814, a heat shock factor 1 (HSF1) pathway inhibitor given orally in patients with advanced cancer.

• IRAS ID

  252524

• Contact name

  Udai Banerji

• Contact email

  Udai.banerji@icr.ac.uk

• Sponsor organisation

  Cancer Research UK

• Eudract number

  2018-000738-36

• Duration of Study in the UK

  3 years, 7 months, 0 days

• Research summary

  This clinical trial is looking at (researching) a drug called CCT361814 which is taken by mouth and looks promising in laboratory studies.

  Cancer cells use a mechanism or pathway to stay alive called the heat shock factor-1 (HSF-1) pathway. This drug blocks the HSF-1 pathway. We now wish to find out if it will be useful in treating patients with cancer.

  The three main aims of this clinical trial are to find out:
  • The maximum dose that can be given safely to patients.
  • More about the potential side effects of CCT361814 and how they can be managed.
  • What happens to CCT361814 inside the body.

  This information will help us decide how much and how often to give CCT361814 to patients with cancer in future clinical trials.
  Patients will be invited to take part in the clinical trial if their current treatment is no longer working and there are no other standard treatments available.
  
  This clinical trial is currently taking place in 1 hospital in the United Kingdom (Royal Marsden Hospital). Further sites may be added in due course. The study is expected to last a total of 3 to 4 years.

  This is a first in human clinical trial where approximately 51 participants will be entered. Initially, participants with advanced solid tumours will receive increasing doses of CCT361814 to find a safe dose (referred to dose escalation). Within the 51 participants on the study, participants may be entered to a dose confirmation cohort to further look at the tolerability of CCT361814 and obtain additional information on the drug. This dose confirmation cohort will be enriched with participants who have clear cell or endomettrioid ovarian cancer.

  This study is sponsored by Cancer Research UK (CRUK) and CCT361814 is developed by the Institute of Cancer Research.

• REC name

  London - Central Research Ethics Committee

• REC reference

  19/LO/0556

• Date of REC Opinion

  8 May 2019

• REC opinion

  Favourable Opinion