ICT01 in combination with IL-2 in patients with advanced solid tumors

• Research type

  Research Study

• Full title

  A two-part, open-label, clinical study to assess the safety, tolerability and activity of intravenous doses of ICT01 in combination with low-dose subcutaneous interleukin-2 in patients with advanced solid tumors (EVICTION-2)

• IRAS ID

  1004819

• Contact name

  Paul Frohna

• Contact email

  paul.frohna@imcheck.fr

• Sponsor organisation

  Imcheck Therapeutics

• Eudract number

  2021-005110-34

• Clinicaltrials.gov Identifier

  NCT05307874

• Research summary

  The objective of this clinical trial is to evaluate the safety, tolerability and efficacy of the
  study drug ICT01 delivered intravenously as a stand-alone therapy and in combination with an already approved
  medication known as an immune checkpoint inhibitor (ICI), in patients with advanced-stage solid tumours or
  haematologic cancers who have not responded to other treatments.
  The study is composed of two parts:
  - 1: dose escalation of ICT01 alone or in combination with an approved anti-cancer drug known as an Immune
  Checkpoint Inhibitor (ICI)
  - 2: expansion stage of ICT01 alone or in combination with an approved ICI the focus is on understanding
  the safety profile, rather than proving its efficacy in treating a disease.
  ”Open-label” means the patient and study doctor will know the treatment received.
  “Dose escalation” means that a range of increasing doses of ICT01 will be administered to patients until significant
  clinical activity or safety and tolerability concerns are identified.
  “Immune Checkpoint Inhibitor” is a type of immunotherapy agent that can help inhibit immune checkpoint
  mechanisms which are often activated and suppress early anti-tumour immune response.
  The main aims of this first part of the study are to evaluate how well ICT01 is tolerated by patients by monitoring side
  effects and to determine the best doses for additional testing. The effects of the product will also be tested as well as
  its efficacy in treating the disease. The highest safe and active doses will be considered as the recommended dose
  for the second part in order to achieve the highest possible efficacy in combating malignant tumours with minimal side
  effects.
  30 patients will be enrolled at 4 sites in the UK.
  197 patients will be enrolled globally across Spain, Germany, France, Belgium and the USA

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  22/LO/0528

• Date of REC Opinion

  26 Sep 2022

• REC opinion

  Further Information Favourable Opinion