A Phase I/II trial of TT-702 in patients with advanced solid tumours

• Research type

  Research Study

• Full title

  CURATE - A Cancer Research UK Phase I/II, dose escalation and expansion trial of TT-702, a selective adenosine A2BR antagonist, given orally as a monotherapy agent and in combination, in patients with advanced solid tumours.

• IRAS ID

  298938

• Contact name

  Johann De Bono

• Contact email

  johann.debono@icr.ac.uk

• Sponsor organisation

  Cancer Research UK

• Eudract number

  2021-001062-37

• Duration of Study in the UK

  4 years, 0 months, 0 days

• Research summary

  This is an open label, multi-centre, first in human, Phase I/II, adaptive design trial in patients with advanced solid tumours. This clinical trial is looking at a drug called ‘TT-702’ used on its own (monotherapy) and with other anti-cancer drugs (in combination). TT-702 is a type of drug called a ‘small molecule prodrug’. TT-702 is converted into TT-478 which then targets and blocks the function of the ‘A2B adenosine receptor’. By blocking this receptor, we hope to kick start the immune system so that it looks for cancer cells with this receptor and helps to fight and stop the cancer cells from growing in size and number.

  This clinical trial has two phases:
  - Phase I, dose escalation phase - groups of patients will receive increasing doses of TT-702 to find a safe dose that best targets the cancer cells. This phase will consist of both monotherapy and combination escalation cohorts.

  - Phase II, expansion phase - larger groups of patients will receive the selected dose of TT-702 considered to be safe in the Phase I, dose escalation phase, to allow us to find out more about how the drug is working. This phase will consist of both monotherapy and combination expansion cohorts.

  The main aims of this trial are to find out:
  - The maximum dose of TT-702 as a monotherapy and in combination with other anti-cancer drugs that can be given safely to patients.
  - More about the potential side effects of TT-702 and how they can be managed.
  - What happens to TT-702 when inside the body.

  This trial will be conducted initially at two UK NHS sites. Additional sites will be identified at a later stage. The trial sponsor is Cancer Research UK (CRUK).
  

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  21/LO/0470

• Date of REC Opinion

  8 Sep 2021

• REC opinion

  Further Information Favourable Opinion